Careers

our commitment

At Gamida Cell, we work tirelessly to enable cures.

We are a global company united by our passion for science, our spirit of relentless innovation, and — above else — our commitment to changing the lives of patients, families and caregivers affected by blood cancers and rare, serious blood diseases.

Hear from members of our team and explore opportunities to join us.

Meet Gamida

“Knowing that every day I work to bring hope and potentially curative therapies to patients makes every day meaningful.”

PlusRocio Manghani, MPH, Senior Vice President, Market Access

“As someone who has worked at the patient’s bedside for years, it is truly inspiring to accompany a patient through such a life-altering treatment process. It gives us the inspiration and motivation to advance our therapies every day.”

PlusEtty Freind, Clinical Project Manager, U.S.

“The work at Gamida Cell is very interesting. In addition, the potential to save lives is a very rewarding aspect and motivates me to contribute my best every day.”

PlusKeren Rosenberg, Executive Assistant, Israel

Working at Gamida

We’re a group of creative, collaborative individuals with diverse experiences and talent who are committed to cures. If you’re interested in joining us, view our current job openings below, or send a resume to careers.us@gamida-cell.com for U.S.- based positions and careers@gamida-cell.com for Israel-based positions. 

Region Account Director – Northeast Region

USA
Read More

Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

The Region Account Director, Account Management is a first line people manager responsible for hiring and leading a high functioning team of account managers in the Northeast region with the goal of ensuring the successful launch of the company’s first commercial product, omidubicel, upon FDA approval. The account manager will be the primary contact for transplant centers to ensure a positive transplant center and patient experience.   The Northeast region is comprised of allogeneic stem cell transplant centers in New Hampshire, Vermont, Massachusetts, Rhode Island, Connecticut, New York, Pennsylvania, New Jersey, Delaware, Maryland, and Ohio. This role will report to the Vice President, Marketing and Account Management.

  • Posting Title: Region Account Director – Northeast Region
  • Function: Account Management
  • Division: Commercial
  • Location: United States, Northeast – field based

Roles and Responsibilities

  • Hire and lead a team of account managers in the Northeast region and ensure they are appropriately onboarded and trained
  • Provide leadership, motivation and direction to the regional team to achieve performance goals
  • Develop and implement a region business plan in line with brand strategy to support the successful launch of omidubicel
  • Monitor market trends to provide input into strategy, identify growth opportunities and ensure launch strategy execution for the region
  • Build strong relationships with national, regional & local allogeneic hematopoietic stem cell transplant physicians to communicate clinical messages and value proposition for omidubicel
  • Ensure education and support is provided to the transplant centers for appropriate receipt, storage and preparation of omidubicel to ensure a positive transplant center and patient experience
  • Align closely with medical affairs and payer team leadership to ensure execution on integrated approach for the region
  • Effectively manage region budget to maximize resources according to the business needs
  • Ensure the region meets or exceeds goals and executes the brand strategy set forth for launch
  • Identify opportunities in the region, share best practices, and proactively communicate strategies for improvements to cross-functional partners and leadership
  • Manage implementation of all promotional activities to support sales and marketing strategies, in accordance with appropriate policies
  • Ensure the highest standards of quality and compliance are maintained by the account management team

Experience, Education and Specialized Knowledge and Skills

  • 10+ years industry experience with 5-7 years of Hematology biotech/pharmaceutical sales leadership/equivalent experience: launch experience and knowledge of Cell and Gene Therapy required
  • BA/BS required: Advanced degree in Business, Marketing, or Life Sciences preferred
  • Highly self-motivated and able to work independently
  • Proven track record of recruiting and retaining top talent
  • Able to learn and coach in a highly complex scientific environment
  • Demonstrated experience in leading strategically, driving performance and fostering collaboration within a cross functional environment
  • Able to rapidly identify issues and effectively implement solutions
  • Adept at presenting to senior leadership on strategy and KPI’s in the region
  • Capable of demonstrating flexibility, problem-solving and change management
  • Committed to making a positive contribution to the company and establish trust and credibility with team members
  • Possesses strong interpersonal and communication skills with an ability to build alignment around goals and objectives
  • Achieves organizational focus while valuing diverse and opposing views among multi-cultural teams 

Travel: 40-60%
Reports to: VP, Marketing and Account Management

To apply: Send resume and cover letter to careers.us@gamida-cell.com

Region Account Director – Rocky Mountains Region

USA
Read More

Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

The Region Account Director, Account Management is a first line people manager responsible for hiring and leading a high functioning team of account managers in the Rocky Mountains region with the goal of ensuring the successful launch of the company’s first commercial product, omidubicel, upon FDA approval. The account manager will be the primary contact for transplant centers to ensure a positive transplant center and patient experience.   The Rocky Mountains region is comprised ofallogeneic stem cell transplant centers in Ohio, Michigan, Indiana, Illinois, Wisconsin, Minnesota, Iowa, Missouri, South Dakota, Nebraska, Kansas, Montana, and Colorado. This role will report to the Vice President, Marketing and Account Management.

  • Posting Title: Region Account Director – Rocky Mountains Region
  • Function: Account Management
  • Division: Commercial
  • Location: United States, Rocky Mountains – field based

Roles and Responsibilities

  • Hire and lead a team of account managers in the Northeast region and ensure they are appropriately onboarded and trained
  • Provide leadership, motivation and direction to the regional team to achieve performance goals
  • Develop and implement a region business plan in line with brand strategy to support the successful launch of omidubicel
  • Monitor market trends to provide input into strategy, identify growth opportunities and ensure launch strategy execution for the region
  • Build strong relationships with national, regional & local allogeneic hematopoietic stem cell transplant physicians to communicate clinical messages and value proposition for omidubicel
  • Ensure education and support is provided to the transplant centers for appropriate receipt, storage and preparation of omidubicel to ensure a positive transplant center and patient experience
  • Align closely with medical affairs and payer team leadership to ensure execution on integrated approach for the region
  • Effectively manage region budget to maximize resources according to the business needs
  • Ensure the region meets or exceeds goals and executes the brand strategy set forth for launch
  • Identify opportunities in the region, share best practices, and proactively communicate strategies for improvements to cross-functional partners and leadership
  • Manage implementation of all promotional activities to support sales and marketing strategies, in accordance with appropriate policies
  • Ensure the highest standards of quality and compliance are maintained by the account management team

Experience, Education and Specialized Knowledge and Skills

  • 10+ years industry experience with 5-7 years of Hematology biotech/pharmaceutical sales leadership/equivalent experience: launch experience and knowledge of Cell and Gene Therapy required
  • BA/BS required: Advanced degree in Business, Marketing, or Life Sciences preferred
  • Highly self-motivated and able to work independently
  • Proven track record of recruiting and retaining top talent
  • Able to learn and coach in a highly complex scientific environment
  • Demonstrated experience in leading strategically, driving performance and fostering collaboration within a cross functional environment
  • Able to rapidly identify issues and effectively implement solutions
  • Adept at presenting to senior leadership on strategy and KPI’s in the region
  • Capable of demonstrating flexibility, problem-solving and change management
  • Committed to making a positive contribution to the company and establish trust and credibility with team members
  • Possesses strong interpersonal and communication skills with an ability to build alignment around goals and objectives
  • Achieves organizational focus while valuing diverse and opposing views among multi-cultural teams 

Travel: 40-60%
Reports to: VP, Marketing and Account Management

To apply: Send resume and cover letter to careers.us@gamida-cell.com

Region Account Director – Southeast Region

USA
Read More

Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

The Region Account Director, Account Management is a first line people manager responsible for hiring and leading a high functioning team of account managers in the Southeast region with the goal of ensuring the successful launch of the company’s first commercial product, omidubicel, upon FDA approval. The account manager will be the primary contact for transplant centers to ensure a positive transplant center and patient experience.   The Southeast region is comprised of allogeneic stem cell transplant centers in Arkansas, Louisiana, Kentucky, Ohio, West Virginia, Virginia, Washington DC, North Carolina, South Carolina, Tennessee, Mississippi, Alabama, Georgia, and Florida. This role will report to the Vice President, Marketing and Account Management.

  • Posting Title: Region Account Director – Southeast Region
  • Function: Account Management
  • Division: Commercial
  • Location: United States, Rocky Mountains – field based

Roles and Responsibilities

  • Hire and lead a team of account managers in the Northeast region and ensure they are appropriately onboarded and trained
  • Provide leadership, motivation and direction to the regional team to achieve performance goals
  • Develop and implement a region business plan in line with brand strategy to support the successful launch of omidubicel
  • Monitor market trends to provide input into strategy, identify growth opportunities and ensure launch strategy execution for the region
  • Build strong relationships with national, regional & local allogeneic hematopoietic stem cell transplant physicians to communicate clinical messages and value proposition for omidubicel
  • Ensure education and support is provided to the transplant centers for appropriate receipt, storage and preparation of omidubicel to ensure a positive transplant center and patient experience
  • Align closely with medical affairs and payer team leadership to ensure execution on integrated approach for the region
  • Effectively manage region budget to maximize resources according to the business needs
  • Ensure the region meets or exceeds goals and executes the brand strategy set forth for launch
  • Identify opportunities in the region, share best practices, and proactively communicate strategies for improvements to cross-functional partners and leadership
  • Manage implementation of all promotional activities to support sales and marketing strategies, in accordance with appropriate policies
  • Ensure the highest standards of quality and compliance are maintained by the account management team

Experience, Education and Specialized Knowledge and Skills

  • 10+ years industry experience with 5-7 years of Hematology biotech/pharmaceutical sales leadership/equivalent experience: launch experience and knowledge of Cell and Gene Therapy required
  • BA/BS required: Advanced degree in Business, Marketing, or Life Sciences preferred
  • Highly self-motivated and able to work independently
  • Proven track record of recruiting and retaining top talent
  • Able to learn and coach in a highly complex scientific environment
  • Demonstrated experience in leading strategically, driving performance and fostering collaboration within a cross functional environment
  • Able to rapidly identify issues and effectively implement solutions
  • Adept at presenting to senior leadership on strategy and KPI’s in the region
  • Capable of demonstrating flexibility, problem-solving and change management
  • Committed to making a positive contribution to the company and establish trust and credibility with team members
  • Possesses strong interpersonal and communication skills with an ability to build alignment around goals and objectives
  • Achieves organizational focus while valuing diverse and opposing views among multi-cultural teams 

Travel: 40-60%
Reports to: VP, Marketing and Account Management

To apply: Send resume and cover letter to careers.us@gamida-cell.com

Region Account Director – West Region

USA
Read More

Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

The Region Account Director, Account Management is a first line people manager responsible for hiring and leading a high functioning team of account managers in the West region with the goal of ensuring the successful launch of the company’s first commercial product, omidubicel, upon FDA approval. The account manager will be the primary contact for transplant centers to ensure a positive transplant center and patient experience.   The West region is comprised of allogeneic stem cell transplant centers in Washington, Oregon, California, Idaho, Utah, Arizona, New Mexico, Texas, Oklahoma, and Hawaii. This role will report to the Vice President, Marketing and Account Management.

  • Posting Title: Region Account Director – West Region
  • Function: Account Management
  • Division: Commercial
  • Location: United States, Region Account Director – field based

Roles and Responsibilities

  • Hire and lead a team of account managers in the Northeast region and ensure they are appropriately onboarded and trained
  • Provide leadership, motivation and direction to the regional team to achieve performance goals
  • Develop and implement a region business plan in line with brand strategy to support the successful launch of omidubicel
  • Monitor market trends to provide input into strategy, identify growth opportunities and ensure launch strategy execution for the region
  • Build strong relationships with national, regional & local allogeneic hematopoietic stem cell transplant physicians to communicate clinical messages and value proposition for omidubicel
  • Ensure education and support is provided to the transplant centers for appropriate receipt, storage and preparation of omidubicel to ensure a positive transplant center and patient experience
  • Align closely with medical affairs and payer team leadership to ensure execution on integrated approach for the region
  • Effectively manage region budget to maximize resources according to the business needs
  • Ensure the region meets or exceeds goals and executes the brand strategy set forth for launch
  • Identify opportunities in the region, share best practices, and proactively communicate strategies for improvements to cross-functional partners and leadership
  • Manage implementation of all promotional activities to support sales and marketing strategies, in accordance with appropriate policies
  • Ensure the highest standards of quality and compliance are maintained by the account management team

Experience, Education and Specialized Knowledge and Skills

  • 10+ years industry experience with 5-7 years of Hematology biotech/pharmaceutical sales leadership/equivalent experience: launch experience and knowledge of Cell and Gene Therapy required
  • BA/BS required: Advanced degree in Business, Marketing, or Life Sciences preferred
  • Highly self-motivated and able to work independently
  • Proven track record of recruiting and retaining top talent
  • Able to learn and coach in a highly complex scientific environment
  • Demonstrated experience in leading strategically, driving performance and fostering collaboration within a cross functional environment
  • Able to rapidly identify issues and effectively implement solutions
  • Adept at presenting to senior leadership on strategy and KPI’s in the region
  • Capable of demonstrating flexibility, problem-solving and change management
  • Committed to making a positive contribution to the company and establish trust and credibility with team members
  • Possesses strong interpersonal and communication skills with an ability to build alignment around goals and objectives
  • Achieves organizational focus while valuing diverse and opposing views among multi-cultural teams 

Travel: 40-60%
Reports to: VP, Marketing and Account Management

To apply: Send resume and cover letter to careers.us@gamida-cell.com

MSL/Senior Medical Science Liaison – Southeast Region

USA
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MSL/Senior Medical Science Liaison 

Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

The Medical Science Liaison (MSL) is the field-based medical/scientific expert for the company, focusing on engagement with healthcare providers to provide fair/balanced education on Gamida Cell investigational products, understanding the evolving therapeutic landscape, and supporting research collaborations across the portfolio. The Senior MSL will share the responsibilities of an MSL and will also consistently demonstrate core competencies and assume broader responsibilities.

Roles and Responsibilities

  • Identifies, establishes, and maintains collaborative relationships with key investigators, institutions, groups and consortia in disease state areas of strategic focus for Gamida Cell.
  • Provides education to the medical community on Gamida Cell investigational products and disease areas of focus.
  • Increases company visibility and enhances professional interaction with current and future oncology leaders.
  • Participates in medical education for healthcare professionals, including formulary (P&T) committees, through presentations at appropriate venues.
  • Works with the appropriate departments/personnel at clinical sites to ensure required education and training are provided as needed.
  • Identifies clinical research opportunities that are consistent with company objectives.
  • Represents (Is) the primary territory contact for the investigator-initiated research program, facilitating the process from concept submission through publication.
  • Identifies and communicates key clinical and research insights from oncology leaders to help shape company research.
  • Maintains a high level of clinical and scientific expertise through ongoing training and self-education, including attendance of relevant conferences, scientific workshops, and review of key publications.
  • Gathers and disseminates competitive intelligence in a compliant manner.
  • Takes advantage of opportunities to mentor other MSL team members, and actively contributes to cross-functional US Medical Affairs teams.
  • For Senior MSL role, substantively contributes to scientific publication planning, slide-deck development, training initiatives and the development/implementation of Medical Strategy Plan
  • For Senior MSL role, leading national level priority projects or cross-functions initiatives on behalf of Medical Affairs
  • For Senior MSL role, leading interactions for specific select priority projects with external collaborators or groups
  • For Senior MSL role, coordinating with MA Training lead for identifying or delivering advanced training initiatives

Experience, Education and Specialized Knowledge and Skills

  • Advanced degree (PhD, PharmD, or MD), with prior experience in the biotech/pharmaceutical industry, is strongly preferred. For Senior MSL, prior experience in pharmaceutical industry medical affairs as MSL.
  • Prior MSL or relevant experience is strongly preferred.
  • Minimum of 5 years hematology/oncology experience is strongly preferred.
  • Clinical research experience is preferred.
  • Knowledge of applicable treatment, compliance, and regulatory guidelines. For Senior MSL, knowledge of treatment guidelines (NCCN, ASCO, ASH, ESMO, etc.) clinical research process, FDA regulations, CMS reimbursement coverage process, and OIG guidelines.
  • Excellent interpersonal communication and presentation skills.
  • Strong problem solving, decision-making, and negotiation skills.
  • Ability to think strategically and apply knowledge and analytical skills.
  • Ability to summarize complex scientific information and present in a clear, concise, confident, and scientifically accurate and balanced manner to a range of audiences.
  • Ability to network and partner with external customers, including medical thought leaders, academic institutions, research consortia, and practice networks. For Senior MSL, this also includes large group practices, NCI Cooperative Group leadership and members, medical directors of medical groups or insurance carriers, as well as pharmacy directors.
  • Thrives in a team environment and enjoys cross-functional collaboration; positively contributes to team culture.
  • Possesses demonstrable effective leadership skills (by example and through accomplishments) and can step forward to handle challenges within scope of authority.
  • Demonstrates deep therapeutic competency; stays abreast of trends and new information in the therapeutic/translational science area, as well as the profession at large.
  • For Senior MSL, must be highly articulate and self-confident during formal and informal presentations; able to convey complex scientific ideas fluently to any audience.

Travel: Approximately 60-70% domestic travel is required; As this is a customer-facing position, and the geographic territory expected to be covered is large, the candidate’s availability for frequent travel is of paramount importance for professional and programmatic success.

Reports to: Senior Director, Medical Affairs

To apply: Send resume and cover letter to careers.us@gamida-cell.com

MSL/Senior Medical Science Liaison – Great Lakes Region

USA
Read More

MSL/Senior Medical Science Liaison 

Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

The Medical Science Liaison (MSL) is the field-based medical/scientific expert for the company, focusing on engagement with healthcare providers to provide fair/balanced education on Gamida Cell investigational products, understanding the evolving therapeutic landscape, and supporting research collaborations across the portfolio. The Senior MSL will share the responsibilities of an MSL and will also consistently demonstrate core competencies and assume broader responsibilities.

Roles and Responsibilities

  • Identifies, establishes, and maintains collaborative relationships with key investigators, institutions, groups and consortia in disease state areas of strategic focus for Gamida Cell.
  • Provides education to the medical community on Gamida Cell investigational products and disease areas of focus.
  • Increases company visibility and enhances professional interaction with current and future oncology leaders.
  • Participates in medical education for healthcare professionals, including formulary (P&T) committees, through presentations at appropriate venues.
  • Works with the appropriate departments/personnel at clinical sites to ensure required education and training are provided as needed.
  • Identifies clinical research opportunities that are consistent with company objectives.
  • Represents (Is) the primary territory contact for the investigator-initiated research program, facilitating the process from concept submission through publication.
  • Identifies and communicates key clinical and research insights from oncology leaders to help shape company research.
  • Maintains a high level of clinical and scientific expertise through ongoing training and self-education, including attendance of relevant conferences, scientific workshops, and review of key publications.
  • Gathers and disseminates competitive intelligence in a compliant manner.
  • Takes advantage of opportunities to mentor other MSL team members, and actively contributes to cross-functional US Medical Affairs teams.
  • For Senior MSL role, substantively contributes to scientific publication planning, slide-deck development, training initiatives and the development/implementation of Medical Strategy Plan
  • For Senior MSL role, leading national level priority projects or cross-functions initiatives on behalf of Medical Affairs
  • For Senior MSL role, leading interactions for specific select priority projects with external collaborators or groups
  • For Senior MSL role, coordinating with MA Training lead for identifying or delivering advanced training initiatives

Experience, Education and Specialized Knowledge and Skills

  • Advanced degree (PhD, PharmD, or MD), with prior experience in the biotech/pharmaceutical industry, is strongly preferred. For Senior MSL, prior experience in pharmaceutical industry medical affairs as MSL.
  • Prior MSL or relevant experience is strongly preferred.
  • Minimum of 5 years hematology/oncology experience is strongly preferred.
  • Clinical research experience is preferred.
  • Knowledge of applicable treatment, compliance, and regulatory guidelines. For Senior MSL, knowledge of treatment guidelines (NCCN, ASCO, ASH, ESMO, etc.) clinical research process, FDA regulations, CMS reimbursement coverage process, and OIG guidelines.
  • Excellent interpersonal communication and presentation skills.
  • Strong problem solving, decision-making, and negotiation skills.
  • Ability to think strategically and apply knowledge and analytical skills.
  • Ability to summarize complex scientific information and present in a clear, concise, confident, and scientifically accurate and balanced manner to a range of audiences.
  • Ability to network and partner with external customers, including medical thought leaders, academic institutions, research consortia, and practice networks. For Senior MSL, this also includes large group practices, NCI Cooperative Group leadership and members, medical directors of medical groups or insurance carriers, as well as pharmacy directors.
  • Thrives in a team environment and enjoys cross-functional collaboration; positively contributes to team culture.
  • Possesses demonstrable effective leadership skills (by example and through accomplishments) and can step forward to handle challenges within scope of authority.
  • Demonstrates deep therapeutic competency; stays abreast of trends and new information in the therapeutic/translational science area, as well as the profession at large.
  • For Senior MSL, must be highly articulate and self-confident during formal and informal presentations; able to convey complex scientific ideas fluently to any audience.

Travel: Approximately 60-70% domestic travel is required; As this is a customer-facing position, and the geographic territory expected to be covered is large, the candidate’s availability for frequent travel is of paramount importance for professional and programmatic success.

Reports to: Senior Director, Medical Affairs

To apply: Send resume and cover letter to careers.us@gamida-cell.com

MSL/Senior Medical Science Liaison – Great Plains Region

USA
Read More

MSL/Senior Medical Science Liaison 

Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

The Medical Science Liaison (MSL) is the field-based medical/scientific expert for the company, focusing on engagement with healthcare providers to provide fair/balanced education on Gamida Cell investigational products, understanding the evolving therapeutic landscape, and supporting research collaborations across the portfolio. The Senior MSL will share the responsibilities of an MSL and will also consistently demonstrate core competencies and assume broader responsibilities.

Roles and Responsibilities

  • Identifies, establishes, and maintains collaborative relationships with key investigators, institutions, groups and consortia in disease state areas of strategic focus for Gamida Cell.
  • Provides education to the medical community on Gamida Cell investigational products and disease areas of focus.
  • Increases company visibility and enhances professional interaction with current and future oncology leaders.
  • Participates in medical education for healthcare professionals, including formulary (P&T) committees, through presentations at appropriate venues.
  • Works with the appropriate departments/personnel at clinical sites to ensure required education and training are provided as needed.
  • Identifies clinical research opportunities that are consistent with company objectives.
  • Represents (Is) the primary territory contact for the investigator-initiated research program, facilitating the process from concept submission through publication.
  • Identifies and communicates key clinical and research insights from oncology leaders to help shape company research.
  • Maintains a high level of clinical and scientific expertise through ongoing training and self-education, including attendance of relevant conferences, scientific workshops, and review of key publications.
  • Gathers and disseminates competitive intelligence in a compliant manner.
  • Takes advantage of opportunities to mentor other MSL team members, and actively contributes to cross-functional US Medical Affairs teams.
  • For Senior MSL role, substantively contributes to scientific publication planning, slide-deck development, training initiatives and the development/implementation of Medical Strategy Plan
  • For Senior MSL role, leading national level priority projects or cross-functions initiatives on behalf of Medical Affairs
  • For Senior MSL role, leading interactions for specific select priority projects with external collaborators or groups
  • For Senior MSL role, coordinating with MA Training lead for identifying or delivering advanced training initiatives

Experience, Education and Specialized Knowledge and Skills

  • Advanced degree (PhD, PharmD, or MD), with prior experience in the biotech/pharmaceutical industry, is strongly preferred. For Senior MSL, prior experience in pharmaceutical industry medical affairs as MSL.
  • Prior MSL or relevant experience is strongly preferred.
  • Minimum of 5 years hematology/oncology experience is strongly preferred.
  • Clinical research experience is preferred.
  • Knowledge of applicable treatment, compliance, and regulatory guidelines. For Senior MSL, knowledge of treatment guidelines (NCCN, ASCO, ASH, ESMO, etc.) clinical research process, FDA regulations, CMS reimbursement coverage process, and OIG guidelines.
  • Excellent interpersonal communication and presentation skills.
  • Strong problem solving, decision-making, and negotiation skills.
  • Ability to think strategically and apply knowledge and analytical skills.
  • Ability to summarize complex scientific information and present in a clear, concise, confident, and scientifically accurate and balanced manner to a range of audiences.
  • Ability to network and partner with external customers, including medical thought leaders, academic institutions, research consortia, and practice networks. For Senior MSL, this also includes large group practices, NCI Cooperative Group leadership and members, medical directors of medical groups or insurance carriers, as well as pharmacy directors.
  • Thrives in a team environment and enjoys cross-functional collaboration; positively contributes to team culture.
  • Possesses demonstrable effective leadership skills (by example and through accomplishments) and can step forward to handle challenges within scope of authority.
  • Demonstrates deep therapeutic competency; stays abreast of trends and new information in the therapeutic/translational science area, as well as the profession at large.
  • For Senior MSL, must be highly articulate and self-confident during formal and informal presentations; able to convey complex scientific ideas fluently to any audience.

Travel: Approximately 60-70% domestic travel is required; As this is a customer-facing position, and the geographic territory expected to be covered is large, the candidate’s availability for frequent travel is of paramount importance for professional and programmatic success.

Reports to: Senior Director, Medical Affairs

To apply: Send resume and cover letter to careers.us@gamida-cell.com

MSL/Senior Medical Science Liaison – Northeast Region

USA
Read More

MSL/Senior Medical Science Liaison 

Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

The Medical Science Liaison (MSL) is the field-based medical/scientific expert for the company, focusing on engagement with healthcare providers to provide fair/balanced education on Gamida Cell investigational products, understanding the evolving therapeutic landscape, and supporting research collaborations across the portfolio. The Senior MSL will share the responsibilities of an MSL and will also consistently demonstrate core competencies and assume broader responsibilities.

Roles and Responsibilities

  • Identifies, establishes, and maintains collaborative relationships with key investigators, institutions, groups and consortia in disease state areas of strategic focus for Gamida Cell.
  • Provides education to the medical community on Gamida Cell investigational products and disease areas of focus.
  • Increases company visibility and enhances professional interaction with current and future oncology leaders.
  • Participates in medical education for healthcare professionals, including formulary (P&T) committees, through presentations at appropriate venues.
  • Works with the appropriate departments/personnel at clinical sites to ensure required education and training are provided as needed.
  • Identifies clinical research opportunities that are consistent with company objectives.
  • Represents (Is) the primary territory contact for the investigator-initiated research program, facilitating the process from concept submission through publication.
  • Identifies and communicates key clinical and research insights from oncology leaders to help shape company research.
  • Maintains a high level of clinical and scientific expertise through ongoing training and self-education, including attendance of relevant conferences, scientific workshops, and review of key publications.
  • Gathers and disseminates competitive intelligence in a compliant manner.
  • Takes advantage of opportunities to mentor other MSL team members, and actively contributes to cross-functional US Medical Affairs teams.
  • For Senior MSL role, substantively contributes to scientific publication planning, slide-deck development, training initiatives and the development/implementation of Medical Strategy Plan
  • For Senior MSL role, leading national level priority projects or cross-functions initiatives on behalf of Medical Affairs
  • For Senior MSL role, leading interactions for specific select priority projects with external collaborators or groups
  • For Senior MSL role, coordinating with MA Training lead for identifying or delivering advanced training initiatives

Experience, Education and Specialized Knowledge and Skills

  • Advanced degree (PhD, PharmD, or MD), with prior experience in the biotech/pharmaceutical industry, is strongly preferred. For Senior MSL, prior experience in pharmaceutical industry medical affairs as MSL.
  • Prior MSL or relevant experience is strongly preferred.
  • Minimum of 5 years hematology/oncology experience is strongly preferred.
  • Clinical research experience is preferred.
  • Knowledge of applicable treatment, compliance, and regulatory guidelines. For Senior MSL, knowledge of treatment guidelines (NCCN, ASCO, ASH, ESMO, etc.) clinical research process, FDA regulations, CMS reimbursement coverage process, and OIG guidelines.
  • Excellent interpersonal communication and presentation skills.
  • Strong problem solving, decision-making, and negotiation skills.
  • Ability to think strategically and apply knowledge and analytical skills.
  • Ability to summarize complex scientific information and present in a clear, concise, confident, and scientifically accurate and balanced manner to a range of audiences.
  • Ability to network and partner with external customers, including medical thought leaders, academic institutions, research consortia, and practice networks. For Senior MSL, this also includes large group practices, NCI Cooperative Group leadership and members, medical directors of medical groups or insurance carriers, as well as pharmacy directors.
  • Thrives in a team environment and enjoys cross-functional collaboration; positively contributes to team culture.
  • Possesses demonstrable effective leadership skills (by example and through accomplishments) and can step forward to handle challenges within scope of authority.
  • Demonstrates deep therapeutic competency; stays abreast of trends and new information in the therapeutic/translational science area, as well as the profession at large.
  • For Senior MSL, must be highly articulate and self-confident during formal and informal presentations; able to convey complex scientific ideas fluently to any audience.

Travel: Approximately 60-70% domestic travel is required; As this is a customer-facing position, and the geographic territory expected to be covered is large, the candidate’s availability for frequent travel is of paramount importance for professional and programmatic success.

Reports to: Senior Director, Medical Affairs

To apply: Send resume and cover letter to careers.us@gamida-cell.com

RA Manager

Israel
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Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

Gamida Cell is looking for a skilled and motivated Regulatory Affairs (RA) Manager to join Gamida Cell’s Regulatory Affairs Development team.

Job Title:  RA Manager
Location: Onsite in Israel
5 NAHUM HAFZADI STREET JERUSALEM L3 95484

Roles and Responsibilities

  • Critical review of development reports, pre-clinical and clinical protocols and reports which are part of regulatory submissions
  • Summarize, compile and review of documents to prepare regulatory submissions and dossiers
  • Manage preparation of submission files, including coordination of input and review by different functional teams and consolidation of their feedback, maintaining high quality and adherence to timelines
  • Manage questions and answers received from Regulatory Authorities including updating labeling
  • Participate into cross-functional meetings to prepare for commercialization (supply chain, labeling) and provide input from a Regulatory perspective
  • Review and write controlled documents and SOPs related to regulatory activities

Experience, Education and Specialized Knowledge and Skills

  • Bachelor’s degree in a Life Sciences related field (Biology/Biotechnology/Medical Sciences) or B.Pharm
  • Minimum 8 years of global RA experience in pharmaceutical/biopharmaceutical industry, including nonclinical, clinical and labeling aspects
  • Experience with managing of global registration of new investigational products
  • Experience with various submissions to FDA, EMA and local EU authorities
  • Understanding and knowledge of FDA and EMA regulatory guidelines for human drugs
  • Good scientific understanding and deduction capabilities
  • Basic knowledge of GMP and GCP principles
  • Technical and regulatory writing skills
  • Excellent verbal and written communication skills in English
  • Meticulous and paying attention to details
  • Good knowledge in Microsoft Office
  • Team player, strong analytical skills and ability to work with a minimal supervision, under pressure and meet deadlines
  • Good personal communication and interaction capabilities
  • Advantage: MSc degree in biology/biotechnology, experience and knowledge in cell therapy, experience with submissions in Japan

Reports to RA Senior Director

To apply: Send resume and cover letter to careers@gamida-cell.com

Associate Director- Lead Case Manager

USA
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Associate Director- Lead Case Manager

Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

The Associate Director- Lead Case Manager is a key role focused on oversight of the Case Managers in order to monitor, as well as provide feedback and/or direction on the team’s activity, achievement of Key Performance Indicators, productivity and quality. This role will help to ensure that processes and procedures are in place to facilitate a patient’s case from enrollment in Gamida Cell Assist through Order fulfillment and case completion. This role will be responsible for providing a positive customer experience throughout the entire process. This position reports to the Director, Cell Therapy Patient Services.

  • Posting Title: Associate Director- Lead Case Manager
  • Function: Commercial
  • Location: Remote

Roles and Responsibilities

  • Monitors daily workload of Gamida Cell Assist Case Managers to ensure adequate staff coverage
  • Act as a back up and floater Case Manager, as needed
  • Subject matter expert on processes and day to day customer activities
  • Assists with conducting customer training and overview of Gamida Cell Assist as customers are onboarded and as needed
  • Identifies operational efficiencies and gaps from the start of the patient enrollment through post infusion
  • Trains other Case Managers on new process or policy changes
  • Ensures Case Management teams are meeting and exceeding all key performance indicators
  • Demonstrates exemplary customer service to internal and external customers
  • Collaboratively works with Gamida Cell Account Management team, Payer Access and Reimbursement teams, and with Cell Therapy Operation team to support tasks needed for patient cases
  • Lead for answering questions related to purchasing of starting material
  • Supports all activities within the Chain of Identity and Chain of Custody processes
  • Assists with reimbursement and appeals of claims, and identifies trends on payer coverage and reimbursement
  • Services as the technology liaison to report any issues with Gamida Cell Assist Hospital and Case Management Portals
  • Assists with updating Standard Operating Procedures and work instructions, as needed and obtains necessary approvals prior to implementation
  • Ensures Gamida Cell Assist team is consistently following HIPAA policy and procedures
  • Interacts with external partners, such as Patient Assistance hub

Experience, Education and Specialized Knowledge and Skills

  • Demonstration of excellent customer service
  • Excellent cross functional collaboration amongst various cultures
  • Proven ability to think strategically and prioritize
  • Exceptional problem-solving skills
  • Exhibits initiative, flexibility, and dependability
  • Customer focused
  • High degree of organization, analytical skills and attention to detail
  • Excellent communication skills, both written and oral
  • 5 years or more of reimbursement/ patient services management experience in pharmaceuticals/biotech/transplant and/or cell therapy
  • Knowledge of Cell Therapy operations, preferred
  • A/B.S required; science related field preferred
  • Healthcare Administration/Policy or Social Work experience a plus, but not required 

Reports to: Director, Cell Therapy Patient Services
To apply: Send resume and cover letter to careers.us@gamida-cell.com.

 

Case Manager

USA
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Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

  • Posting Title: Case Manager
  • Function: Commercial
  • Location: Remote

General Scope and Summary

The Case Manager is an instrumental role focused on facilitating a patient’s case from enrollment in Gamida Cell Assist through Order fulfillment and case completion. This role will be responsible for providing a positive customer experience throughout the entire process. This position reports to the Associate Director, Lead Case Manager.

Roles and Responsibilities

  • Point of contact for transplant centers when ordering Gamida Cell product
  • Manages patient cases from patient enrollment through case completion
  • Answers incoming Gamida Cell Assist calls and warm transfers from hospital administrators, patients and Gamida Cell team members
  • Provides exemplary customer service to internal and external customers
  • Interface between Gamida Cell Assist Account Management and Field Quality teams regarding dry runs
  • Notifies Gamida Cell management team of sites interested in ordering omidubicel if site is not currently onboarded
  • Trains onboarded sites on how to appropriately utilize Gamida Cell Assist’s hospital portal
  • Works with Be The Match Case Managers to ensure appropriate coordination of shipping of the starting material
  • Supports all activities from enrolling of patients, ordering the starting material, receipt of starting materials, through shipping of final product to site
  • Works with Cell Therapy Operations team to ensure knowledge of where Gamida Cell product is in the manufacturing process
  • Liaise with transplant centers as it pertains to their order
  • Reviews new cases to ensure enrollment is complete and patient and transplant center information is accurate and complete
  • Confirms final order prior to solidifying manufacturing slot
  • Works with transplant centers to ensure appropriate and timely delivery of final product
  • Conduct welcome call to patients/caregiver for patients who have opted into patient assistance services, including travel and lodging support
  • Coordinates patient and caregiver travel logistics with selected vendor and assists with coordinating pick up and drop off addresses
  • Collaborates with Account Management and Payer Access and Reimbursement teams 

Experience, Education and Specialized Knowledge and Skills

  • Demonstration of excellent customer service
  • Excellent cross functional collaboration amongst various cultures
  • Proven ability to think strategically and prioritize
  • Exceptional problem-solving skills
  • Exhibits initiative, flexibility, and dependability
  • Customer focused
  • High degree of organization, analytical skills and attention to detail
  • Excellent communication skills, both written and oral
  • 3 years or more of case management/ reimbursement/ patient services experience in pharmaceuticals/biotech, transplant and/or cell therapy preferred
  • Knowledge of Cell Therapy operations, preferred
  • Bachelor’s Degree
  • Social Work or Nursing experience a plus, but not required

Reports to: Associate Director, Lead Case Manager
To apply: Send resume and cover letter to careers.us@gamida-cell.com.

Director, Field Quality Assurance

USA
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Director, Field Quality Assurance

Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

The Director of Field QA will work cross functionally to lead the assessment and monitoring program for transplant centers (TC) that supports commercial sites and expansion to new commercial products. This role will be a hands-on resource reporting to Quality.

  • Company: Gamida Cell, Ltd.
  • Posting Title: Director, Field Quality Assurance
  • Function: Quality
  • Location: Remote

Roles and Responsibilities

  • Establish and execute and improve the TC assessment process that will use risk- based tools for assessment, training, monitoring, in addition to expansion of the program to new commercial products
  • Collaborate with Commercial, Medical Affairs, Regulatory, IT, Clinical Operations, Manufacturing, Operations and Supply Chain to execute and improve processes that include the interlinked process elements of patient identification, COI/COC and logistics
  • Perform selection assessment requirements
  • Develop and execute TC change management process, related to the hospital site changes, that includes equipment, process and product management
  • Manage the assessment and monitoring schedule of approved TC list
  • Quality contact for TC issues and discrepancies with GCA, Medical Affairs Call Center and Operations Quality
  • Support inspection readiness plans and interact with regulatory agencies during inspections on TC related matters
  • Lead and develop a team that executes and improves TC assessment program
  • Perform other duties as assigned

Experience, Education and Specialized Knowledge and Skills

  • Bachelor’s degree in biological sciences or related field; Master’s degree preferred
  • Minimum of 10 years progressive experience in pharmaceutical or biologics quality systems’ roles; biologics, blood/human tissue, cell therapy or vaccines experience preferred
  • Minimum of 3-5 years of management/leadership experience
  • Experience auditing and assessing TC preferred. External suppliers, and/or internal GMP systems audits
  • ASQ Certified Quality Auditor preferred
  • Strong working knowledge of and ability to apply GMP and FACT guidelines in conformance to US, EU and ROW standards
  • Experience presenting and responding to regulatory agency, internal and/or corporate audits
  • Proficient in MS Word, Excel, and Power Point
  • Demonstrated ability to develop, coach, and mentor employees
  • Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment with external medical professionals and internal Commercial colleagues
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description

Travel: Ability to travel up to 60%
Reports to: QA Director, Quality Systems

To apply: Send resume and cover letter to careers.us@gamida-cell.com

 

Quality Assurance Associate – Manufacturing

Israel
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Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

Job Description

  • Ensure GMP compliance of Gamida Cell facilities to support global IND, CTA, BLA and MAA submissions, PAI inspections, and commercial manufacturing activities
  • Prepare, review and approve master documents related to Manufacturing (including SOPs, test methods, validation protocols and reports)
  • Contribute to investigations, risk assessments, change controls, deviations, and CAPAs
  • Review and approve executed manufacturing and testing records for clinical production
  • Support on site and virtual audit activities, to ensure ongoing compliance
  • Conduct routine internal audits of the Manufacturing and support areas to verify compliance with cGMP
  • Provide on-the-floor QA oversight during manufacturing activities, as needed
  • Ensure that Manufacturing personnel work according to regulatory guidelines and relevant procedures
  • Approve labels issued for clinical batches manufactured by Gamida Cell
  • Prepare and approve CoAs for clinical batches manufactured by Gamida Cell
  • Provide QA oversight clinical product shipment, as needed

Experience, Education and Specialized Knowledge and Skills

  • Bachelor’s degree or higher in science-related field, or equivalent work experience
  • Experience in a GMP Quality, Engineering or Manufacturing role (or combination thereof) within a commercial biopharmaceutical, cellular therapy, or gene therapy organization (Minimum of 2 years)
  • Competent in the application of cGMP principles and change control
  • Proficient in root cause analysis and risk assessment methodologies
  • Knowledge of Quality Assurance requirements in the FDA and EMA regions is required
  • Experience with Regulatory Inspections is preferred
  • Excellent computer proficiency (MS Office – Word, Excel, Power Point and Outlook)
  • Fluent English

 To apply: Send resume and cover letter to careers@gamida-cell.com.

Head of Government Affairs and Policy

USA
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Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

The Head of Government Affairs and Policy is a key role focused on ensuring that patients have timely access to therapy by reducing access barriers and creating policies that support patient access.  The Head of Government Affairs and Policy will be the subject matter expert as it pertains to healthcare legislation, policies and CMS coverage/reimbursement. He/she is responsible for the development and execution of comprehensive government affairs and policy strategies as it pertains to the interactions with elected officials and to advance Gamida Cell’s reputation and interests with trade/advocacy organizations, CMS and policy makers on a federal and state basis. This role will require significant cross functional responsibilities with Market Access, Corporate Affairs, Legal, Marketing, Medical Affairs and other key functions.

Roles and Responsibilities

  • Develop proactive strategic and tactical plans to engage with key decision-makers to shape CMS regulations and federal/state legislation that impact access to Gamida Cell therapies
  • Cultivate effective relationships on behalf of Gamida Cell with key HHS/CMS/CMMI staff and officials, key policy makers, trade/advocacy organizations and opinion leaders resulting in meaningful partnerships focused on patient access
  • Coordinate and lead Gamida Cell meetings with HHS/CMS, as well as federal and state officials, and other policy organizations and coalitions
  • Liase with trade/advocacy groups that support protecting patient’s access to innovative therapies
  • Monitor and assess regulations and legislations to determine any impact to Gamida Cell
  • Serve as an internal expert on the healthcare policy environment to help executive team identify threats and opportunities for Gamida Cell
  • Support the external engagement of Gamida Cell executives with elected officials and other key stakeholders within and around the US federal government
  • In conjunction with legal and compliance, ensure compliance with relevant federal laws regarding lobbying activities, as appropriate
  • Oversee and manage Government Affairs partner agencies

Experience, Education and Specialized Knowledge and Skills

  • 12+ years’ experience in Federal Government Affairs and Policy
  • Expertise in state and federal government levels
  • Ability to connect key business needs and patient access to public policy and regulations to advance business interests and reputation of Gamida Cell
  • Holistic view of the impact of federal agency regulations, state and federal policies and health policies
  • Thorough knowledge of domestic government policies that impact pharmaceutical companies
  • Ex-US government policies knowledge is a plus
  • Excellent judgment to make decisions on complex business and healthcare policy issues and act based on what is in the best interests of the company and patients
  • Strong business acumen and the ability to manage multiple priorities, processes, timelines and expectations of multiple stakeholder groups
  • Demonstrated ability to be viewed as trustworthy and credible
  • Ability to relay complex information in a concise format, both verbally and and written to senior executives
  • Combination of analytical, organizational and interpersonal skills
  • Strong problem solving skills
  • Knowledge of Cell Therapy, preferred
  • B.A/B.S required
  • Graduate degree in Healthcare Administration/Policy or Social Work experience a plus

Location: Remote-Preferred location Washington, DC
Travel: Up to 50% travel anticipated
To apply: Send resume and cover letter to careers.us@gamida-cell.com

Region Account Director – Northeast Region

USA
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Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

The Region Account Director, Account Management is a first line people manager responsible for hiring and leading a high functioning team of account managers in the Northeast region with the goal of ensuring the successful launch of the company’s first commercial product, omidubicel, upon FDA approval. The account manager will be the primary contact for transplant centers to ensure a positive transplant center and patient experience.   The Northeast region is comprised of allogeneic stem cell transplant centers in New Hampshire, Vermont, Massachusetts, Rhode Island, Connecticut, New York, Pennsylvania, New Jersey, Delaware, Maryland, and Ohio. This role will report to the Vice President, Marketing and Account Management.

  • Posting Title: Region Account Director – Northeast Region
  • Function: Account Management
  • Division: Commercial
  • Location: United States, Northeast – field based

Roles and Responsibilities

  • Hire and lead a team of account managers in the Northeast region and ensure they are appropriately onboarded and trained
  • Provide leadership, motivation and direction to the regional team to achieve performance goals
  • Develop and implement a region business plan in line with brand strategy to support the successful launch of omidubicel
  • Monitor market trends to provide input into strategy, identify growth opportunities and ensure launch strategy execution for the region
  • Build strong relationships with national, regional & local allogeneic hematopoietic stem cell transplant physicians to communicate clinical messages and value proposition for omidubicel
  • Ensure education and support is provided to the transplant centers for appropriate receipt, storage and preparation of omidubicel to ensure a positive transplant center and patient experience
  • Align closely with medical affairs and payer team leadership to ensure execution on integrated approach for the region
  • Effectively manage region budget to maximize resources according to the business needs
  • Ensure the region meets or exceeds goals and executes the brand strategy set forth for launch
  • Identify opportunities in the region, share best practices, and proactively communicate strategies for improvements to cross-functional partners and leadership
  • Manage implementation of all promotional activities to support sales and marketing strategies, in accordance with appropriate policies
  • Ensure the highest standards of quality and compliance are maintained by the account management team

Experience, Education and Specialized Knowledge and Skills

  • 10+ years industry experience with 5-7 years of Hematology biotech/pharmaceutical sales leadership/equivalent experience: launch experience and knowledge of Cell and Gene Therapy required
  • BA/BS required: Advanced degree in Business, Marketing, or Life Sciences preferred
  • Highly self-motivated and able to work independently
  • Proven track record of recruiting and retaining top talent
  • Able to learn and coach in a highly complex scientific environment
  • Demonstrated experience in leading strategically, driving performance and fostering collaboration within a cross functional environment
  • Able to rapidly identify issues and effectively implement solutions
  • Adept at presenting to senior leadership on strategy and KPI’s in the region
  • Capable of demonstrating flexibility, problem-solving and change management
  • Committed to making a positive contribution to the company and establish trust and credibility with team members
  • Possesses strong interpersonal and communication skills with an ability to build alignment around goals and objectives
  • Achieves organizational focus while valuing diverse and opposing views among multi-cultural teams 

Travel: 40-60%
Reports to: VP, Marketing and Account Management

To apply: Send resume and cover letter to careers.us@gamida-cell.com

Region Account Director – Rocky Mountains Region

USA
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Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

The Region Account Director, Account Management is a first line people manager responsible for hiring and leading a high functioning team of account managers in the Rocky Mountains region with the goal of ensuring the successful launch of the company’s first commercial product, omidubicel, upon FDA approval. The account manager will be the primary contact for transplant centers to ensure a positive transplant center and patient experience.   The Rocky Mountains region is comprised ofallogeneic stem cell transplant centers in Ohio, Michigan, Indiana, Illinois, Wisconsin, Minnesota, Iowa, Missouri, South Dakota, Nebraska, Kansas, Montana, and Colorado. This role will report to the Vice President, Marketing and Account Management.

  • Posting Title: Region Account Director – Rocky Mountains Region
  • Function: Account Management
  • Division: Commercial
  • Location: United States, Rocky Mountains – field based

Roles and Responsibilities

  • Hire and lead a team of account managers in the Northeast region and ensure they are appropriately onboarded and trained
  • Provide leadership, motivation and direction to the regional team to achieve performance goals
  • Develop and implement a region business plan in line with brand strategy to support the successful launch of omidubicel
  • Monitor market trends to provide input into strategy, identify growth opportunities and ensure launch strategy execution for the region
  • Build strong relationships with national, regional & local allogeneic hematopoietic stem cell transplant physicians to communicate clinical messages and value proposition for omidubicel
  • Ensure education and support is provided to the transplant centers for appropriate receipt, storage and preparation of omidubicel to ensure a positive transplant center and patient experience
  • Align closely with medical affairs and payer team leadership to ensure execution on integrated approach for the region
  • Effectively manage region budget to maximize resources according to the business needs
  • Ensure the region meets or exceeds goals and executes the brand strategy set forth for launch
  • Identify opportunities in the region, share best practices, and proactively communicate strategies for improvements to cross-functional partners and leadership
  • Manage implementation of all promotional activities to support sales and marketing strategies, in accordance with appropriate policies
  • Ensure the highest standards of quality and compliance are maintained by the account management team

Experience, Education and Specialized Knowledge and Skills

  • 10+ years industry experience with 5-7 years of Hematology biotech/pharmaceutical sales leadership/equivalent experience: launch experience and knowledge of Cell and Gene Therapy required
  • BA/BS required: Advanced degree in Business, Marketing, or Life Sciences preferred
  • Highly self-motivated and able to work independently
  • Proven track record of recruiting and retaining top talent
  • Able to learn and coach in a highly complex scientific environment
  • Demonstrated experience in leading strategically, driving performance and fostering collaboration within a cross functional environment
  • Able to rapidly identify issues and effectively implement solutions
  • Adept at presenting to senior leadership on strategy and KPI’s in the region
  • Capable of demonstrating flexibility, problem-solving and change management
  • Committed to making a positive contribution to the company and establish trust and credibility with team members
  • Possesses strong interpersonal and communication skills with an ability to build alignment around goals and objectives
  • Achieves organizational focus while valuing diverse and opposing views among multi-cultural teams 

Travel: 40-60%
Reports to: VP, Marketing and Account Management

To apply: Send resume and cover letter to careers.us@gamida-cell.com

Region Account Director – Southeast Region

USA
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Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

The Region Account Director, Account Management is a first line people manager responsible for hiring and leading a high functioning team of account managers in the Southeast region with the goal of ensuring the successful launch of the company’s first commercial product, omidubicel, upon FDA approval. The account manager will be the primary contact for transplant centers to ensure a positive transplant center and patient experience.   The Southeast region is comprised of allogeneic stem cell transplant centers in Arkansas, Louisiana, Kentucky, Ohio, West Virginia, Virginia, Washington DC, North Carolina, South Carolina, Tennessee, Mississippi, Alabama, Georgia, and Florida. This role will report to the Vice President, Marketing and Account Management.

  • Posting Title: Region Account Director – Southeast Region
  • Function: Account Management
  • Division: Commercial
  • Location: United States, Rocky Mountains – field based

Roles and Responsibilities

  • Hire and lead a team of account managers in the Northeast region and ensure they are appropriately onboarded and trained
  • Provide leadership, motivation and direction to the regional team to achieve performance goals
  • Develop and implement a region business plan in line with brand strategy to support the successful launch of omidubicel
  • Monitor market trends to provide input into strategy, identify growth opportunities and ensure launch strategy execution for the region
  • Build strong relationships with national, regional & local allogeneic hematopoietic stem cell transplant physicians to communicate clinical messages and value proposition for omidubicel
  • Ensure education and support is provided to the transplant centers for appropriate receipt, storage and preparation of omidubicel to ensure a positive transplant center and patient experience
  • Align closely with medical affairs and payer team leadership to ensure execution on integrated approach for the region
  • Effectively manage region budget to maximize resources according to the business needs
  • Ensure the region meets or exceeds goals and executes the brand strategy set forth for launch
  • Identify opportunities in the region, share best practices, and proactively communicate strategies for improvements to cross-functional partners and leadership
  • Manage implementation of all promotional activities to support sales and marketing strategies, in accordance with appropriate policies
  • Ensure the highest standards of quality and compliance are maintained by the account management team

Experience, Education and Specialized Knowledge and Skills

  • 10+ years industry experience with 5-7 years of Hematology biotech/pharmaceutical sales leadership/equivalent experience: launch experience and knowledge of Cell and Gene Therapy required
  • BA/BS required: Advanced degree in Business, Marketing, or Life Sciences preferred
  • Highly self-motivated and able to work independently
  • Proven track record of recruiting and retaining top talent
  • Able to learn and coach in a highly complex scientific environment
  • Demonstrated experience in leading strategically, driving performance and fostering collaboration within a cross functional environment
  • Able to rapidly identify issues and effectively implement solutions
  • Adept at presenting to senior leadership on strategy and KPI’s in the region
  • Capable of demonstrating flexibility, problem-solving and change management
  • Committed to making a positive contribution to the company and establish trust and credibility with team members
  • Possesses strong interpersonal and communication skills with an ability to build alignment around goals and objectives
  • Achieves organizational focus while valuing diverse and opposing views among multi-cultural teams 

Travel: 40-60%
Reports to: VP, Marketing and Account Management

To apply: Send resume and cover letter to careers.us@gamida-cell.com

Region Account Director – West Region

USA
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Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

The Region Account Director, Account Management is a first line people manager responsible for hiring and leading a high functioning team of account managers in the West region with the goal of ensuring the successful launch of the company’s first commercial product, omidubicel, upon FDA approval. The account manager will be the primary contact for transplant centers to ensure a positive transplant center and patient experience.   The West region is comprised of allogeneic stem cell transplant centers in Washington, Oregon, California, Idaho, Utah, Arizona, New Mexico, Texas, Oklahoma, and Hawaii. This role will report to the Vice President, Marketing and Account Management.

  • Posting Title: Region Account Director – West Region
  • Function: Account Management
  • Division: Commercial
  • Location: United States, Region Account Director – field based

Roles and Responsibilities

  • Hire and lead a team of account managers in the Northeast region and ensure they are appropriately onboarded and trained
  • Provide leadership, motivation and direction to the regional team to achieve performance goals
  • Develop and implement a region business plan in line with brand strategy to support the successful launch of omidubicel
  • Monitor market trends to provide input into strategy, identify growth opportunities and ensure launch strategy execution for the region
  • Build strong relationships with national, regional & local allogeneic hematopoietic stem cell transplant physicians to communicate clinical messages and value proposition for omidubicel
  • Ensure education and support is provided to the transplant centers for appropriate receipt, storage and preparation of omidubicel to ensure a positive transplant center and patient experience
  • Align closely with medical affairs and payer team leadership to ensure execution on integrated approach for the region
  • Effectively manage region budget to maximize resources according to the business needs
  • Ensure the region meets or exceeds goals and executes the brand strategy set forth for launch
  • Identify opportunities in the region, share best practices, and proactively communicate strategies for improvements to cross-functional partners and leadership
  • Manage implementation of all promotional activities to support sales and marketing strategies, in accordance with appropriate policies
  • Ensure the highest standards of quality and compliance are maintained by the account management team

Experience, Education and Specialized Knowledge and Skills

  • 10+ years industry experience with 5-7 years of Hematology biotech/pharmaceutical sales leadership/equivalent experience: launch experience and knowledge of Cell and Gene Therapy required
  • BA/BS required: Advanced degree in Business, Marketing, or Life Sciences preferred
  • Highly self-motivated and able to work independently
  • Proven track record of recruiting and retaining top talent
  • Able to learn and coach in a highly complex scientific environment
  • Demonstrated experience in leading strategically, driving performance and fostering collaboration within a cross functional environment
  • Able to rapidly identify issues and effectively implement solutions
  • Adept at presenting to senior leadership on strategy and KPI’s in the region
  • Capable of demonstrating flexibility, problem-solving and change management
  • Committed to making a positive contribution to the company and establish trust and credibility with team members
  • Possesses strong interpersonal and communication skills with an ability to build alignment around goals and objectives
  • Achieves organizational focus while valuing diverse and opposing views among multi-cultural teams 

Travel: 40-60%
Reports to: VP, Marketing and Account Management

To apply: Send resume and cover letter to careers.us@gamida-cell.com

MSL/Senior Medical Science Liaison – Southeast Region

USA
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MSL/Senior Medical Science Liaison 

Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

The Medical Science Liaison (MSL) is the field-based medical/scientific expert for the company, focusing on engagement with healthcare providers to provide fair/balanced education on Gamida Cell investigational products, understanding the evolving therapeutic landscape, and supporting research collaborations across the portfolio. The Senior MSL will share the responsibilities of an MSL and will also consistently demonstrate core competencies and assume broader responsibilities.

Roles and Responsibilities

  • Identifies, establishes, and maintains collaborative relationships with key investigators, institutions, groups and consortia in disease state areas of strategic focus for Gamida Cell.
  • Provides education to the medical community on Gamida Cell investigational products and disease areas of focus.
  • Increases company visibility and enhances professional interaction with current and future oncology leaders.
  • Participates in medical education for healthcare professionals, including formulary (P&T) committees, through presentations at appropriate venues.
  • Works with the appropriate departments/personnel at clinical sites to ensure required education and training are provided as needed.
  • Identifies clinical research opportunities that are consistent with company objectives.
  • Represents (Is) the primary territory contact for the investigator-initiated research program, facilitating the process from concept submission through publication.
  • Identifies and communicates key clinical and research insights from oncology leaders to help shape company research.
  • Maintains a high level of clinical and scientific expertise through ongoing training and self-education, including attendance of relevant conferences, scientific workshops, and review of key publications.
  • Gathers and disseminates competitive intelligence in a compliant manner.
  • Takes advantage of opportunities to mentor other MSL team members, and actively contributes to cross-functional US Medical Affairs teams.
  • For Senior MSL role, substantively contributes to scientific publication planning, slide-deck development, training initiatives and the development/implementation of Medical Strategy Plan
  • For Senior MSL role, leading national level priority projects or cross-functions initiatives on behalf of Medical Affairs
  • For Senior MSL role, leading interactions for specific select priority projects with external collaborators or groups
  • For Senior MSL role, coordinating with MA Training lead for identifying or delivering advanced training initiatives

Experience, Education and Specialized Knowledge and Skills

  • Advanced degree (PhD, PharmD, or MD), with prior experience in the biotech/pharmaceutical industry, is strongly preferred. For Senior MSL, prior experience in pharmaceutical industry medical affairs as MSL.
  • Prior MSL or relevant experience is strongly preferred.
  • Minimum of 5 years hematology/oncology experience is strongly preferred.
  • Clinical research experience is preferred.
  • Knowledge of applicable treatment, compliance, and regulatory guidelines. For Senior MSL, knowledge of treatment guidelines (NCCN, ASCO, ASH, ESMO, etc.) clinical research process, FDA regulations, CMS reimbursement coverage process, and OIG guidelines.
  • Excellent interpersonal communication and presentation skills.
  • Strong problem solving, decision-making, and negotiation skills.
  • Ability to think strategically and apply knowledge and analytical skills.
  • Ability to summarize complex scientific information and present in a clear, concise, confident, and scientifically accurate and balanced manner to a range of audiences.
  • Ability to network and partner with external customers, including medical thought leaders, academic institutions, research consortia, and practice networks. For Senior MSL, this also includes large group practices, NCI Cooperative Group leadership and members, medical directors of medical groups or insurance carriers, as well as pharmacy directors.
  • Thrives in a team environment and enjoys cross-functional collaboration; positively contributes to team culture.
  • Possesses demonstrable effective leadership skills (by example and through accomplishments) and can step forward to handle challenges within scope of authority.
  • Demonstrates deep therapeutic competency; stays abreast of trends and new information in the therapeutic/translational science area, as well as the profession at large.
  • For Senior MSL, must be highly articulate and self-confident during formal and informal presentations; able to convey complex scientific ideas fluently to any audience.

Travel: Approximately 60-70% domestic travel is required; As this is a customer-facing position, and the geographic territory expected to be covered is large, the candidate’s availability for frequent travel is of paramount importance for professional and programmatic success.

Reports to: Senior Director, Medical Affairs

To apply: Send resume and cover letter to careers.us@gamida-cell.com

MSL/Senior Medical Science Liaison – Great Lakes Region

USA
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MSL/Senior Medical Science Liaison 

Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

The Medical Science Liaison (MSL) is the field-based medical/scientific expert for the company, focusing on engagement with healthcare providers to provide fair/balanced education on Gamida Cell investigational products, understanding the evolving therapeutic landscape, and supporting research collaborations across the portfolio. The Senior MSL will share the responsibilities of an MSL and will also consistently demonstrate core competencies and assume broader responsibilities.

Roles and Responsibilities

  • Identifies, establishes, and maintains collaborative relationships with key investigators, institutions, groups and consortia in disease state areas of strategic focus for Gamida Cell.
  • Provides education to the medical community on Gamida Cell investigational products and disease areas of focus.
  • Increases company visibility and enhances professional interaction with current and future oncology leaders.
  • Participates in medical education for healthcare professionals, including formulary (P&T) committees, through presentations at appropriate venues.
  • Works with the appropriate departments/personnel at clinical sites to ensure required education and training are provided as needed.
  • Identifies clinical research opportunities that are consistent with company objectives.
  • Represents (Is) the primary territory contact for the investigator-initiated research program, facilitating the process from concept submission through publication.
  • Identifies and communicates key clinical and research insights from oncology leaders to help shape company research.
  • Maintains a high level of clinical and scientific expertise through ongoing training and self-education, including attendance of relevant conferences, scientific workshops, and review of key publications.
  • Gathers and disseminates competitive intelligence in a compliant manner.
  • Takes advantage of opportunities to mentor other MSL team members, and actively contributes to cross-functional US Medical Affairs teams.
  • For Senior MSL role, substantively contributes to scientific publication planning, slide-deck development, training initiatives and the development/implementation of Medical Strategy Plan
  • For Senior MSL role, leading national level priority projects or cross-functions initiatives on behalf of Medical Affairs
  • For Senior MSL role, leading interactions for specific select priority projects with external collaborators or groups
  • For Senior MSL role, coordinating with MA Training lead for identifying or delivering advanced training initiatives

Experience, Education and Specialized Knowledge and Skills

  • Advanced degree (PhD, PharmD, or MD), with prior experience in the biotech/pharmaceutical industry, is strongly preferred. For Senior MSL, prior experience in pharmaceutical industry medical affairs as MSL.
  • Prior MSL or relevant experience is strongly preferred.
  • Minimum of 5 years hematology/oncology experience is strongly preferred.
  • Clinical research experience is preferred.
  • Knowledge of applicable treatment, compliance, and regulatory guidelines. For Senior MSL, knowledge of treatment guidelines (NCCN, ASCO, ASH, ESMO, etc.) clinical research process, FDA regulations, CMS reimbursement coverage process, and OIG guidelines.
  • Excellent interpersonal communication and presentation skills.
  • Strong problem solving, decision-making, and negotiation skills.
  • Ability to think strategically and apply knowledge and analytical skills.
  • Ability to summarize complex scientific information and present in a clear, concise, confident, and scientifically accurate and balanced manner to a range of audiences.
  • Ability to network and partner with external customers, including medical thought leaders, academic institutions, research consortia, and practice networks. For Senior MSL, this also includes large group practices, NCI Cooperative Group leadership and members, medical directors of medical groups or insurance carriers, as well as pharmacy directors.
  • Thrives in a team environment and enjoys cross-functional collaboration; positively contributes to team culture.
  • Possesses demonstrable effective leadership skills (by example and through accomplishments) and can step forward to handle challenges within scope of authority.
  • Demonstrates deep therapeutic competency; stays abreast of trends and new information in the therapeutic/translational science area, as well as the profession at large.
  • For Senior MSL, must be highly articulate and self-confident during formal and informal presentations; able to convey complex scientific ideas fluently to any audience.

Travel: Approximately 60-70% domestic travel is required; As this is a customer-facing position, and the geographic territory expected to be covered is large, the candidate’s availability for frequent travel is of paramount importance for professional and programmatic success.

Reports to: Senior Director, Medical Affairs

To apply: Send resume and cover letter to careers.us@gamida-cell.com

MSL/Senior Medical Science Liaison – Great Plains Region

USA
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MSL/Senior Medical Science Liaison 

Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

The Medical Science Liaison (MSL) is the field-based medical/scientific expert for the company, focusing on engagement with healthcare providers to provide fair/balanced education on Gamida Cell investigational products, understanding the evolving therapeutic landscape, and supporting research collaborations across the portfolio. The Senior MSL will share the responsibilities of an MSL and will also consistently demonstrate core competencies and assume broader responsibilities.

Roles and Responsibilities

  • Identifies, establishes, and maintains collaborative relationships with key investigators, institutions, groups and consortia in disease state areas of strategic focus for Gamida Cell.
  • Provides education to the medical community on Gamida Cell investigational products and disease areas of focus.
  • Increases company visibility and enhances professional interaction with current and future oncology leaders.
  • Participates in medical education for healthcare professionals, including formulary (P&T) committees, through presentations at appropriate venues.
  • Works with the appropriate departments/personnel at clinical sites to ensure required education and training are provided as needed.
  • Identifies clinical research opportunities that are consistent with company objectives.
  • Represents (Is) the primary territory contact for the investigator-initiated research program, facilitating the process from concept submission through publication.
  • Identifies and communicates key clinical and research insights from oncology leaders to help shape company research.
  • Maintains a high level of clinical and scientific expertise through ongoing training and self-education, including attendance of relevant conferences, scientific workshops, and review of key publications.
  • Gathers and disseminates competitive intelligence in a compliant manner.
  • Takes advantage of opportunities to mentor other MSL team members, and actively contributes to cross-functional US Medical Affairs teams.
  • For Senior MSL role, substantively contributes to scientific publication planning, slide-deck development, training initiatives and the development/implementation of Medical Strategy Plan
  • For Senior MSL role, leading national level priority projects or cross-functions initiatives on behalf of Medical Affairs
  • For Senior MSL role, leading interactions for specific select priority projects with external collaborators or groups
  • For Senior MSL role, coordinating with MA Training lead for identifying or delivering advanced training initiatives

Experience, Education and Specialized Knowledge and Skills

  • Advanced degree (PhD, PharmD, or MD), with prior experience in the biotech/pharmaceutical industry, is strongly preferred. For Senior MSL, prior experience in pharmaceutical industry medical affairs as MSL.
  • Prior MSL or relevant experience is strongly preferred.
  • Minimum of 5 years hematology/oncology experience is strongly preferred.
  • Clinical research experience is preferred.
  • Knowledge of applicable treatment, compliance, and regulatory guidelines. For Senior MSL, knowledge of treatment guidelines (NCCN, ASCO, ASH, ESMO, etc.) clinical research process, FDA regulations, CMS reimbursement coverage process, and OIG guidelines.
  • Excellent interpersonal communication and presentation skills.
  • Strong problem solving, decision-making, and negotiation skills.
  • Ability to think strategically and apply knowledge and analytical skills.
  • Ability to summarize complex scientific information and present in a clear, concise, confident, and scientifically accurate and balanced manner to a range of audiences.
  • Ability to network and partner with external customers, including medical thought leaders, academic institutions, research consortia, and practice networks. For Senior MSL, this also includes large group practices, NCI Cooperative Group leadership and members, medical directors of medical groups or insurance carriers, as well as pharmacy directors.
  • Thrives in a team environment and enjoys cross-functional collaboration; positively contributes to team culture.
  • Possesses demonstrable effective leadership skills (by example and through accomplishments) and can step forward to handle challenges within scope of authority.
  • Demonstrates deep therapeutic competency; stays abreast of trends and new information in the therapeutic/translational science area, as well as the profession at large.
  • For Senior MSL, must be highly articulate and self-confident during formal and informal presentations; able to convey complex scientific ideas fluently to any audience.

Travel: Approximately 60-70% domestic travel is required; As this is a customer-facing position, and the geographic territory expected to be covered is large, the candidate’s availability for frequent travel is of paramount importance for professional and programmatic success.

Reports to: Senior Director, Medical Affairs

To apply: Send resume and cover letter to careers.us@gamida-cell.com

MSL/Senior Medical Science Liaison – Northeast Region

USA
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MSL/Senior Medical Science Liaison 

Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

The Medical Science Liaison (MSL) is the field-based medical/scientific expert for the company, focusing on engagement with healthcare providers to provide fair/balanced education on Gamida Cell investigational products, understanding the evolving therapeutic landscape, and supporting research collaborations across the portfolio. The Senior MSL will share the responsibilities of an MSL and will also consistently demonstrate core competencies and assume broader responsibilities.

Roles and Responsibilities

  • Identifies, establishes, and maintains collaborative relationships with key investigators, institutions, groups and consortia in disease state areas of strategic focus for Gamida Cell.
  • Provides education to the medical community on Gamida Cell investigational products and disease areas of focus.
  • Increases company visibility and enhances professional interaction with current and future oncology leaders.
  • Participates in medical education for healthcare professionals, including formulary (P&T) committees, through presentations at appropriate venues.
  • Works with the appropriate departments/personnel at clinical sites to ensure required education and training are provided as needed.
  • Identifies clinical research opportunities that are consistent with company objectives.
  • Represents (Is) the primary territory contact for the investigator-initiated research program, facilitating the process from concept submission through publication.
  • Identifies and communicates key clinical and research insights from oncology leaders to help shape company research.
  • Maintains a high level of clinical and scientific expertise through ongoing training and self-education, including attendance of relevant conferences, scientific workshops, and review of key publications.
  • Gathers and disseminates competitive intelligence in a compliant manner.
  • Takes advantage of opportunities to mentor other MSL team members, and actively contributes to cross-functional US Medical Affairs teams.
  • For Senior MSL role, substantively contributes to scientific publication planning, slide-deck development, training initiatives and the development/implementation of Medical Strategy Plan
  • For Senior MSL role, leading national level priority projects or cross-functions initiatives on behalf of Medical Affairs
  • For Senior MSL role, leading interactions for specific select priority projects with external collaborators or groups
  • For Senior MSL role, coordinating with MA Training lead for identifying or delivering advanced training initiatives

Experience, Education and Specialized Knowledge and Skills

  • Advanced degree (PhD, PharmD, or MD), with prior experience in the biotech/pharmaceutical industry, is strongly preferred. For Senior MSL, prior experience in pharmaceutical industry medical affairs as MSL.
  • Prior MSL or relevant experience is strongly preferred.
  • Minimum of 5 years hematology/oncology experience is strongly preferred.
  • Clinical research experience is preferred.
  • Knowledge of applicable treatment, compliance, and regulatory guidelines. For Senior MSL, knowledge of treatment guidelines (NCCN, ASCO, ASH, ESMO, etc.) clinical research process, FDA regulations, CMS reimbursement coverage process, and OIG guidelines.
  • Excellent interpersonal communication and presentation skills.
  • Strong problem solving, decision-making, and negotiation skills.
  • Ability to think strategically and apply knowledge and analytical skills.
  • Ability to summarize complex scientific information and present in a clear, concise, confident, and scientifically accurate and balanced manner to a range of audiences.
  • Ability to network and partner with external customers, including medical thought leaders, academic institutions, research consortia, and practice networks. For Senior MSL, this also includes large group practices, NCI Cooperative Group leadership and members, medical directors of medical groups or insurance carriers, as well as pharmacy directors.
  • Thrives in a team environment and enjoys cross-functional collaboration; positively contributes to team culture.
  • Possesses demonstrable effective leadership skills (by example and through accomplishments) and can step forward to handle challenges within scope of authority.
  • Demonstrates deep therapeutic competency; stays abreast of trends and new information in the therapeutic/translational science area, as well as the profession at large.
  • For Senior MSL, must be highly articulate and self-confident during formal and informal presentations; able to convey complex scientific ideas fluently to any audience.

Travel: Approximately 60-70% domestic travel is required; As this is a customer-facing position, and the geographic territory expected to be covered is large, the candidate’s availability for frequent travel is of paramount importance for professional and programmatic success.

Reports to: Senior Director, Medical Affairs

To apply: Send resume and cover letter to careers.us@gamida-cell.com

Associate Director- Lead Case Manager

USA
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Associate Director- Lead Case Manager

Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

The Associate Director- Lead Case Manager is a key role focused on oversight of the Case Managers in order to monitor, as well as provide feedback and/or direction on the team’s activity, achievement of Key Performance Indicators, productivity and quality. This role will help to ensure that processes and procedures are in place to facilitate a patient’s case from enrollment in Gamida Cell Assist through Order fulfillment and case completion. This role will be responsible for providing a positive customer experience throughout the entire process. This position reports to the Director, Cell Therapy Patient Services.

  • Posting Title: Associate Director- Lead Case Manager
  • Function: Commercial
  • Location: Remote

Roles and Responsibilities

  • Monitors daily workload of Gamida Cell Assist Case Managers to ensure adequate staff coverage
  • Act as a back up and floater Case Manager, as needed
  • Subject matter expert on processes and day to day customer activities
  • Assists with conducting customer training and overview of Gamida Cell Assist as customers are onboarded and as needed
  • Identifies operational efficiencies and gaps from the start of the patient enrollment through post infusion
  • Trains other Case Managers on new process or policy changes
  • Ensures Case Management teams are meeting and exceeding all key performance indicators
  • Demonstrates exemplary customer service to internal and external customers
  • Collaboratively works with Gamida Cell Account Management team, Payer Access and Reimbursement teams, and with Cell Therapy Operation team to support tasks needed for patient cases
  • Lead for answering questions related to purchasing of starting material
  • Supports all activities within the Chain of Identity and Chain of Custody processes
  • Assists with reimbursement and appeals of claims, and identifies trends on payer coverage and reimbursement
  • Services as the technology liaison to report any issues with Gamida Cell Assist Hospital and Case Management Portals
  • Assists with updating Standard Operating Procedures and work instructions, as needed and obtains necessary approvals prior to implementation
  • Ensures Gamida Cell Assist team is consistently following HIPAA policy and procedures
  • Interacts with external partners, such as Patient Assistance hub

Experience, Education and Specialized Knowledge and Skills

  • Demonstration of excellent customer service
  • Excellent cross functional collaboration amongst various cultures
  • Proven ability to think strategically and prioritize
  • Exceptional problem-solving skills
  • Exhibits initiative, flexibility, and dependability
  • Customer focused
  • High degree of organization, analytical skills and attention to detail
  • Excellent communication skills, both written and oral
  • 5 years or more of reimbursement/ patient services management experience in pharmaceuticals/biotech/transplant and/or cell therapy
  • Knowledge of Cell Therapy operations, preferred
  • A/B.S required; science related field preferred
  • Healthcare Administration/Policy or Social Work experience a plus, but not required 

Reports to: Director, Cell Therapy Patient Services
To apply: Send resume and cover letter to careers.us@gamida-cell.com.

 

Case Manager

USA
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Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

  • Posting Title: Case Manager
  • Function: Commercial
  • Location: Remote

General Scope and Summary

The Case Manager is an instrumental role focused on facilitating a patient’s case from enrollment in Gamida Cell Assist through Order fulfillment and case completion. This role will be responsible for providing a positive customer experience throughout the entire process. This position reports to the Associate Director, Lead Case Manager.

Roles and Responsibilities

  • Point of contact for transplant centers when ordering Gamida Cell product
  • Manages patient cases from patient enrollment through case completion
  • Answers incoming Gamida Cell Assist calls and warm transfers from hospital administrators, patients and Gamida Cell team members
  • Provides exemplary customer service to internal and external customers
  • Interface between Gamida Cell Assist Account Management and Field Quality teams regarding dry runs
  • Notifies Gamida Cell management team of sites interested in ordering omidubicel if site is not currently onboarded
  • Trains onboarded sites on how to appropriately utilize Gamida Cell Assist’s hospital portal
  • Works with Be The Match Case Managers to ensure appropriate coordination of shipping of the starting material
  • Supports all activities from enrolling of patients, ordering the starting material, receipt of starting materials, through shipping of final product to site
  • Works with Cell Therapy Operations team to ensure knowledge of where Gamida Cell product is in the manufacturing process
  • Liaise with transplant centers as it pertains to their order
  • Reviews new cases to ensure enrollment is complete and patient and transplant center information is accurate and complete
  • Confirms final order prior to solidifying manufacturing slot
  • Works with transplant centers to ensure appropriate and timely delivery of final product
  • Conduct welcome call to patients/caregiver for patients who have opted into patient assistance services, including travel and lodging support
  • Coordinates patient and caregiver travel logistics with selected vendor and assists with coordinating pick up and drop off addresses
  • Collaborates with Account Management and Payer Access and Reimbursement teams 

Experience, Education and Specialized Knowledge and Skills

  • Demonstration of excellent customer service
  • Excellent cross functional collaboration amongst various cultures
  • Proven ability to think strategically and prioritize
  • Exceptional problem-solving skills
  • Exhibits initiative, flexibility, and dependability
  • Customer focused
  • High degree of organization, analytical skills and attention to detail
  • Excellent communication skills, both written and oral
  • 3 years or more of case management/ reimbursement/ patient services experience in pharmaceuticals/biotech, transplant and/or cell therapy preferred
  • Knowledge of Cell Therapy operations, preferred
  • Bachelor’s Degree
  • Social Work or Nursing experience a plus, but not required

Reports to: Associate Director, Lead Case Manager
To apply: Send resume and cover letter to careers.us@gamida-cell.com.

Director, Field Quality Assurance

USA
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Director, Field Quality Assurance

Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

The Director of Field QA will work cross functionally to lead the assessment and monitoring program for transplant centers (TC) that supports commercial sites and expansion to new commercial products. This role will be a hands-on resource reporting to Quality.

  • Company: Gamida Cell, Ltd.
  • Posting Title: Director, Field Quality Assurance
  • Function: Quality
  • Location: Remote

Roles and Responsibilities

  • Establish and execute and improve the TC assessment process that will use risk- based tools for assessment, training, monitoring, in addition to expansion of the program to new commercial products
  • Collaborate with Commercial, Medical Affairs, Regulatory, IT, Clinical Operations, Manufacturing, Operations and Supply Chain to execute and improve processes that include the interlinked process elements of patient identification, COI/COC and logistics
  • Perform selection assessment requirements
  • Develop and execute TC change management process, related to the hospital site changes, that includes equipment, process and product management
  • Manage the assessment and monitoring schedule of approved TC list
  • Quality contact for TC issues and discrepancies with GCA, Medical Affairs Call Center and Operations Quality
  • Support inspection readiness plans and interact with regulatory agencies during inspections on TC related matters
  • Lead and develop a team that executes and improves TC assessment program
  • Perform other duties as assigned

Experience, Education and Specialized Knowledge and Skills

  • Bachelor’s degree in biological sciences or related field; Master’s degree preferred
  • Minimum of 10 years progressive experience in pharmaceutical or biologics quality systems’ roles; biologics, blood/human tissue, cell therapy or vaccines experience preferred
  • Minimum of 3-5 years of management/leadership experience
  • Experience auditing and assessing TC preferred. External suppliers, and/or internal GMP systems audits
  • ASQ Certified Quality Auditor preferred
  • Strong working knowledge of and ability to apply GMP and FACT guidelines in conformance to US, EU and ROW standards
  • Experience presenting and responding to regulatory agency, internal and/or corporate audits
  • Proficient in MS Word, Excel, and Power Point
  • Demonstrated ability to develop, coach, and mentor employees
  • Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment with external medical professionals and internal Commercial colleagues
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description

Travel: Ability to travel up to 60%
Reports to: QA Director, Quality Systems

To apply: Send resume and cover letter to careers.us@gamida-cell.com

 

Head of Government Affairs and Policy

USA
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Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

The Head of Government Affairs and Policy is a key role focused on ensuring that patients have timely access to therapy by reducing access barriers and creating policies that support patient access.  The Head of Government Affairs and Policy will be the subject matter expert as it pertains to healthcare legislation, policies and CMS coverage/reimbursement. He/she is responsible for the development and execution of comprehensive government affairs and policy strategies as it pertains to the interactions with elected officials and to advance Gamida Cell’s reputation and interests with trade/advocacy organizations, CMS and policy makers on a federal and state basis. This role will require significant cross functional responsibilities with Market Access, Corporate Affairs, Legal, Marketing, Medical Affairs and other key functions.

Roles and Responsibilities

  • Develop proactive strategic and tactical plans to engage with key decision-makers to shape CMS regulations and federal/state legislation that impact access to Gamida Cell therapies
  • Cultivate effective relationships on behalf of Gamida Cell with key HHS/CMS/CMMI staff and officials, key policy makers, trade/advocacy organizations and opinion leaders resulting in meaningful partnerships focused on patient access
  • Coordinate and lead Gamida Cell meetings with HHS/CMS, as well as federal and state officials, and other policy organizations and coalitions
  • Liase with trade/advocacy groups that support protecting patient’s access to innovative therapies
  • Monitor and assess regulations and legislations to determine any impact to Gamida Cell
  • Serve as an internal expert on the healthcare policy environment to help executive team identify threats and opportunities for Gamida Cell
  • Support the external engagement of Gamida Cell executives with elected officials and other key stakeholders within and around the US federal government
  • In conjunction with legal and compliance, ensure compliance with relevant federal laws regarding lobbying activities, as appropriate
  • Oversee and manage Government Affairs partner agencies

Experience, Education and Specialized Knowledge and Skills

  • 12+ years’ experience in Federal Government Affairs and Policy
  • Expertise in state and federal government levels
  • Ability to connect key business needs and patient access to public policy and regulations to advance business interests and reputation of Gamida Cell
  • Holistic view of the impact of federal agency regulations, state and federal policies and health policies
  • Thorough knowledge of domestic government policies that impact pharmaceutical companies
  • Ex-US government policies knowledge is a plus
  • Excellent judgment to make decisions on complex business and healthcare policy issues and act based on what is in the best interests of the company and patients
  • Strong business acumen and the ability to manage multiple priorities, processes, timelines and expectations of multiple stakeholder groups
  • Demonstrated ability to be viewed as trustworthy and credible
  • Ability to relay complex information in a concise format, both verbally and and written to senior executives
  • Combination of analytical, organizational and interpersonal skills
  • Strong problem solving skills
  • Knowledge of Cell Therapy, preferred
  • B.A/B.S required
  • Graduate degree in Healthcare Administration/Policy or Social Work experience a plus

Location: Remote-Preferred location Washington, DC
Travel: Up to 50% travel anticipated
To apply: Send resume and cover letter to careers.us@gamida-cell.com

RA Manager

Israel
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Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

General Scope and Summary

Gamida Cell is looking for a skilled and motivated Regulatory Affairs (RA) Manager to join Gamida Cell’s Regulatory Affairs Development team.

Job Title:  RA Manager
Location: Onsite in Israel
5 NAHUM HAFZADI STREET JERUSALEM L3 95484

Roles and Responsibilities

  • Critical review of development reports, pre-clinical and clinical protocols and reports which are part of regulatory submissions
  • Summarize, compile and review of documents to prepare regulatory submissions and dossiers
  • Manage preparation of submission files, including coordination of input and review by different functional teams and consolidation of their feedback, maintaining high quality and adherence to timelines
  • Manage questions and answers received from Regulatory Authorities including updating labeling
  • Participate into cross-functional meetings to prepare for commercialization (supply chain, labeling) and provide input from a Regulatory perspective
  • Review and write controlled documents and SOPs related to regulatory activities

Experience, Education and Specialized Knowledge and Skills

  • Bachelor’s degree in a Life Sciences related field (Biology/Biotechnology/Medical Sciences) or B.Pharm
  • Minimum 8 years of global RA experience in pharmaceutical/biopharmaceutical industry, including nonclinical, clinical and labeling aspects
  • Experience with managing of global registration of new investigational products
  • Experience with various submissions to FDA, EMA and local EU authorities
  • Understanding and knowledge of FDA and EMA regulatory guidelines for human drugs
  • Good scientific understanding and deduction capabilities
  • Basic knowledge of GMP and GCP principles
  • Technical and regulatory writing skills
  • Excellent verbal and written communication skills in English
  • Meticulous and paying attention to details
  • Good knowledge in Microsoft Office
  • Team player, strong analytical skills and ability to work with a minimal supervision, under pressure and meet deadlines
  • Good personal communication and interaction capabilities
  • Advantage: MSc degree in biology/biotechnology, experience and knowledge in cell therapy, experience with submissions in Japan

Reports to RA Senior Director

To apply: Send resume and cover letter to careers@gamida-cell.com

Quality Assurance Associate – Manufacturing

Israel
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Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

Job Description

  • Ensure GMP compliance of Gamida Cell facilities to support global IND, CTA, BLA and MAA submissions, PAI inspections, and commercial manufacturing activities
  • Prepare, review and approve master documents related to Manufacturing (including SOPs, test methods, validation protocols and reports)
  • Contribute to investigations, risk assessments, change controls, deviations, and CAPAs
  • Review and approve executed manufacturing and testing records for clinical production
  • Support on site and virtual audit activities, to ensure ongoing compliance
  • Conduct routine internal audits of the Manufacturing and support areas to verify compliance with cGMP
  • Provide on-the-floor QA oversight during manufacturing activities, as needed
  • Ensure that Manufacturing personnel work according to regulatory guidelines and relevant procedures
  • Approve labels issued for clinical batches manufactured by Gamida Cell
  • Prepare and approve CoAs for clinical batches manufactured by Gamida Cell
  • Provide QA oversight clinical product shipment, as needed

Experience, Education and Specialized Knowledge and Skills

  • Bachelor’s degree or higher in science-related field, or equivalent work experience
  • Experience in a GMP Quality, Engineering or Manufacturing role (or combination thereof) within a commercial biopharmaceutical, cellular therapy, or gene therapy organization (Minimum of 2 years)
  • Competent in the application of cGMP principles and change control
  • Proficient in root cause analysis and risk assessment methodologies
  • Knowledge of Quality Assurance requirements in the FDA and EMA regions is required
  • Experience with Regulatory Inspections is preferred
  • Excellent computer proficiency (MS Office – Word, Excel, Power Point and Outlook)
  • Fluent English

 To apply: Send resume and cover letter to careers@gamida-cell.com.