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

“Our success results from teams working together with a common mission and focus as we enter the next chapter of our story.”

PlusLindsay Luke, VP, Professional Alliances, U.S.

“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, New Jersey

“My vision for my role at Gamida Cell is to contribute to our success by working to develop therapies that are used to treat and potentially cure many patients with hematologic malignancies and solid tumors.”

PlusYair Steinhardt, Research Projects Manager, 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@gamida-cell.com.

Senior Director, Global Health Economics & Outcomes Research

USA
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Gamida Cell is a clinical-stage biopharmaceutical company committed to developing novel cell therapies with the potential to cure difficult-to-treat cancers and rare, serious hematologic diseases. We are leveraging our proprietary nicotinamide-based cell expansion technology, or NAM technology, to develop product candidates designed to address the limitations of current therapies. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy in development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution. Omidubicel is currently being evaluated in an international, multi-center, randomized Phase 3 study in patients with high-risk blood cancers.

The Senior Director, Global Health Economics & Outcomes Research (HEOR) will play a critical and significant role in the growth of Gamida Cell as an organization and in the successful commercialization of its novel cellular therapy pipeline products. The HEOR lead will work at a global level to lead the development of HEOR research strategies and plans to support optimal market access for the therapies. In addition, they will support the development and submission of in-country Health Technology Assessment (HTA) and Pricing & Reimbursement (P&R) submissions. The person in this leadership position will also represent HEOR at internal review groups and in front of Executive leadership as well as to our external Market Access customers.

KEY RESPONSIBILITIES

The Sr. Director of Global HEOR will:

  • Develop global HEOR strategies including analyses of currently available data and generate plans to fill identified gaps.
  • Develop HEOR engagement strategies specific to payers and stakeholders in the US, Europe and Israel.
  • Manage relationships with external consultants to ensure timely completion of high-quality projects aligned to strategic objectives.
  • Design, implement, and manage HEOR projects, including but not limited to:
      • Retrospective database analyses o Heath economic models.
      • Budget impact models.
      • Chart reviews.
      • Real world evidence o Literature searches and systematic review.
  • Support development and maintenance of global value dossiers.
  • Identify appropriate data sources to support the projects described above.
  • Conduct economic analyses and/or conduct detailed reviews of existing analyses.
  • Work with KOLs to implement HEOR plans.
  • Communicate study plans, study methods and results to internal teams.
  • Present health outcomes research findings at scientific congresses and participate in the development and writing of manuscripts for publication in peer-reviewed journals.
  • Build strong relationships with internal stakeholders and ensure continuous and consistent communication with key internal partners on HEOR projects.
  • Represent HEOR on cross-functional internal teams.
  • Remain current on HEOR data sources and analytical methods.
  • Work with clinical development teams to identify appropriate trial endpoints for products in development.
  • Work closely with US and Israeli colleagues, and external consultants to develop strategies specific to US, European or Israeli payers and stakeholders.
  • Lead consultancy support in the development of in-country HTA and P&R dossiers.
  • Identify appropriate US, European or Israeli data sources.
  • Other projects and activities as assigned.

QUALIFICATIONS

  • Proven expertise in Health Economics / Outcomes Research.
  • At least 5 years pharma/biotech experience with HEOR strategy and implementation in US and Europe.
  • Understanding market access and how HEOR evidence supports access decisions.
  • Country and regional/global experience within a pharmaceutical company or consultancy
  • Hematology/oncology experience required.
  • Cell therapy, rare disease, orphan or ultra-orphan product experience highly desirable.
  • Life sciences degree; post-graduate degree preferred.
  • Excellent verbal and written communication skills.
  • Excellent analytical skills, including in-depth knowledge of health economic modeling.
  • Experience in managing multiple projects across a variety of health outcomes methodologies and therapeutic areas.
  • Solid understanding of epidemiology and biostatistics.

EDUCATION

  • Minimum masters degree, scientific or technical area.
  • Preferred advanced degree related to health economics and/or outcomes research.
  • Fluent in English, written and oral.

ADDITIONAL

  • Travel: Up to 40%, once travel resumes

Vice President, Medical Affairs

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. Omidubicel is currently being evaluated in an international, multi-center, randomized Phase 3 study in patients with high-risk blood cancers, and positive topline data from the study were reported in May 2020.

General Scope and Summary

Gamida Cell is at an exciting inflection point for the business, preparing for a successful launch of its lead product, omidubicel, and seeks a Vice President, Medical Affairs to develop and lead a highly efficient and integrated medical function, including scientific evidence generation and scientific information exchange with all key stakeholders.

Reporting to the Chief Medical Officer, this individual will be a member of the Clinical Leadership Team and a key partner internally with the global Commercial, Market Access, Clinical, and Communications teams, as well as externally with key opinion leaders, healthcare professionals and payors.

Over time, the VP Medical Affairs will build a team of internally and externally facing professionals, including medical science liaisons and MDs. This position will have a strong outward-facing presence in the U.S. and global KOL community and requires domestic and international travel.

The individual will be passionate about the portfolio, have high energy in daily duties, and be optimistic about Gamida Cell’s trajectory and goals.

The Vice President of Medical Affairs will build and maintain a strong, world-class organization that is aligned around global medical strategies and ensures execution of strategy through the management of complex relationships with multiple stakeholders both within and outside of the company.

Roles and Responsibilities

  • Develop and lead medical affairs strategies including medical communications, engagement with opinion leaders, investigator-led research, data dissemination, and external collaborations.
  • Lead the development of medical affairs activities including publication planning, medical advisory boards, educational programs, conferences, and responding to requests for medical information.
  • Provide medical expertise and collaborate in the development of strategies for commercial, market access, business development, and public relations activities.
  • Establish professional relationships with the medical community and exchange scientific knowledge with global and regional key opinion leaders.
  • Partner with Commercial to ensure timely, accurate, and compliant preparation and review of promotional and educational material.
  • Establish and execute a strategic publication and congress plan; work with internal colleagues to develop key messages on unmet need, mechanism of action, target product profile, and other materials.

Experience, Education and Specialized Knowledge and Skills

  • Academic Training: Doctoral degree in clinical specialty required (M.D., Ph.D., Pharm D.) with experience in hematology/oncology and/or bone marrow transplant.
  • Industry Experience: A minimum of 10 years of experience in the pharmaceutical or biotech industries.
  • Medical Affairs Experience: Demonstrated ability to develop scientific plans in support of end game product differentiation, customer needs, and clinical practice patterns that lead to prescribing. Experience and demonstrated track record in a medical affairs leadership role in the US, marketing and commercially savvy and robust understanding of late stage development projects and regulatory space. Understanding of evolving environmental and market access issues.
  • Product Launch Experience: Demonstrated record of product launches in the US and ability to bring strategic insight to commercialization plans. Global launch experience ideal but not a must.
  • Leadership Experience: Visionary and entrepreneurial, with experience in building, leading, driving and engaging a successful team. Strong executive presence as equally as a hands-on mind-set. Outstanding communication skills and ability to work effectively in a diverse global corporate environment.

Travel: 30%, once travel resumes

Reports to: Chief Medical Officer

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

Vice President, Marketing and Account Management

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. Omidubicel is currently being evaluated in an international, multi-center, randomized Phase 3 study in patients with high-risk blood cancers, and positive topline data from the study were reported in May 2020.

General Scope and Summary

Gamida Cell is at an exciting inflection point for the business, preparing for a successful launch of its lead product, omidubicel, and seeks a Vice President, Marketing and Account Management to develop and lead a highly efficient and effective marketing and account management function to successfully enable availability to omidubicel as well as build the foundation of our marketing and account management capabilities to ensure the success of future products.

Roles and Responsibilities

  • Leading the omidubicel brand essence development and preparing omidubicel for launch in the U.S.
  • Leading the development of the commercial strategy for the NAM platform therapies, including omidubicel, GDA-201 and future therapies
  • Serving as the cross functional launch readiness lead for omidubicel and future launches
  • Leading the development of the brand strategy and overseeing the marketing team implementation
  • Developing the account management team including defining strategy, roles and responsibilities, policies, processes/procedures, tools and technologies, and incentives
  • Leading the implementation of the cross-functional launch plan
  • Representing commercial on the regulatory team, including label development and finalization
  • Supporting the professional alliance team with the development of the thought leader interaction plan, integrated professional society/advocacy plans and congress planning activities
  • Leading the government affairs initiatives for Gamida Cell
  • Developing the commercial training plan and providing oversight for implementation
  • Partnering with market access and medical affairs for the development of the health economics strategy and analyses
  • Partnering with market access to align the market access strategy with the overall commercial strategy
  • Partnering with market access to finalize the strategy and operations for the Gamida assist team
  • Achieving the commercial goals as defined by the metrics in the launch score card
  • Overseeing the establishment of the account management team objectives and incentive compensation/bonus structure
  • Key partnering with commercial operations and IT in the development of the business requirements for account management tools and systems implementation
  • Managing the budget associated with marketing, account management team, and any commercial launch related expenses
  • Key partnering with commercial analytics in market research, forecasting, performance tracking and business reviews
  • Building a culture of compliance to ensure that all commercial activities are fully compliant with company policies and legal and regulatory guidelines
  • Coaching, training, and mentoring team members; sourcing key talent internally and externally to maintain a bench of strong leaders
  • Contributing as a critical stakeholder to cross-functional partners strategic plans

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to set a commercial vision and strategy for products and functional teams at the corporate level and translate and communicate with clarity into actionable plans; excellent analytical skills and an ability to communicate complex issues in a simple way to executives and to orchestrate plans to resolve issues and mitigate risks.

  • 15+ years related experience in the biotechnology industry with a proven, consistent history of high performance in a broad range of leadership roles of increasing responsibility
  • 8+ years of progressive sales leadership experience with demonstrated results as a Marketing and Field Force leader
  • B.A./B.S. degree required. Advanced degree in Business, Marketing or Life Sciences preferred
  • Significant product launch experience in a marketing, sales or account management leadership roles
  • Demonstrates exceptional leadership, management and communication skills to inspire sales and account management teams to achieve high levels of performance
  • Strong executive presence with the ability to set vision and strategy for sales and account management at the national level and lead the organization through large scale change
  • Must have experience building out and leading new teams and functions
  • Demonstrated success leading teams of account managers responsible for securing product access and pull through in hospitals / health systems is pivotal to the role
  • Expert level knowledge of pricing and reimbursement and market access strategies across therapeutic treatment settings.
  • Brand marketing and national/regional payer account management experience is highly desired
  • Strong team player who has a customer service approach and is solution oriented
  • Attention to detail and the ability to work individually and across a multi-disciplinary leadership team, as well as with multiple external partners and vendors
  • Possesses strong written and verbal communication skills

Travel: ~50% Travel once travel resumes

Reports to: Chief Operating and Chief Commercial Officer

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

Director, Regulatory Affairs

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. Omidubicel is currently being evaluated in an international, multi-center, randomized Phase 3 study in patients with high-risk blood cancers, and positive topline data from the study were reported in May 2020.

General Scope and Summary

Gamida Cell is looking for a Regulatory Affairs leader to join the team for directing innovative global regulatory strategies for product development and approval. Responsible for defining strategies for meeting and keeping post approval compliance. Responsible for regulatory documents, submissions, and compliance issues. Represent the company with domestic and international regulatory authorities, contractors and corporate partners. Provide regulatory support for various departments, projects, and teams/committees. Provide mentorship and leadership to others, both direct reports as well as cross-functionally.

Roles and Responsibilities

  • Effectively establish, resource and manage the company’s regulatory affairs function in USA, providing strong leadership and focus.
  • Develop and implement appropriate regulatory labelling strategies to support marketing applications for U.S., EU and other RoW territories of the company’s development candidates.
  • Ensure that the company’s products are developed to be regionally compliant and that they remain in regulatory compliance; define strategies to mitigate risks.
  • Keep abreast of new FDA regulatory requirements (as well as those from other key international regulatory authorities) and anticipate their future impact on Gamida Cell.
  • Develop and maintain strong relationships with health authorities/regulators, contractors and corporate partners while negotiating on behalf of Gamida Cell.
  • Promote a positive work environment by communicating a clear direction on goals, provide support to other areas, and work in a fashion consistent with Gamida Cells’ values.
  • Play a substantive role in the preparation of submission-relevant documents relating to Gamida’s development activities, including BLA and MAA submissions, label extensions, post-approval regulatory obligations, etc.
  • Play a key role in providing guidance and advice to product development project teams with respect to regulatory requirements and trends affecting corporate strategy, programs, business development and processes.
  • Assess compliance of CMC documents with current guidelines and regulations. Recommend strategies to achieve such compliance; assess impact of proposed CMC changes to licenses or clinical trial applications.
  • Oversee regulatory promotional compliance.
  • Provide input to Executive Management team(s).
  • Actively participate in and contribute to outside relevant conferences, including organizing and delivering presentations.

Experience, Education and Specialized Knowledge and Skills

  • BS degree in sciences, preferably life sciences.
  • 8 years pharmaceutical/biotechnology industry experience with technical management experience.
  • Minimum of 6 years in RA, with in-depth knowledge of applicable regulations.
  • Experience in interpretation of regulations, guidelines, policy statements, etc.
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
  • Experience in interfacing with relevant regulatory authorities.
  • Foster effective, positive interactions with regulatory agencies, and corporate partners.
  • Ability to lead, influence and represent project teams, committees, external meeting etc. to attain group goals.
  • Demonstrate excellent leadership, organization and communication skills.
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
  • Strong sensitivity for a multicultural/multinational environment.
  • Ability to guide, train, mentor, supervise and prioritize workload of direct reports. 

Travel: 20%, once travel resumes

Reports to: Chief Regulatory Affairs and Quality Assurance Office

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

Program Manager

Israel
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. Omidubicel is currently being evaluated in an international, multi-center, randomized Phase 3 study in patients with high-risk blood cancers, and positive topline data from the study were reported in May 2020.

General Scope and Summary

This is an exciting opportunity to work in a multi-faceted program management role.  The Program Manager will provide project management support to the cross-functional program teams to successfully support the progression of drug development projects in all phases. These responsibilities will include managing program plans, timelines, critical path activities and operations support at all levels to ensure seamless execution of the program. The Program Manager provides support and facilitates proactive planning, issues identification and risk mitigation discussions with the cross-functional program teams and Executive Leadership to ensure successful and timely execution of programs. The Program Manager will ensure that the program strategy is clearly integrated into the project budget and operational plans. Initially the key responsibilities will be for the omidubicel program and other earlier programs, as applicable.

Roles and Responsibilities

  • Develop and maintain detailed project plans, monitors progress to timelines and budget, supports resource management, risk management and change management to deliver against agreed strategic objectives.
  • Establish cross-functional team and coordinate meetings to support research, development, clinical, manufacturing, and regulatory activities, including setting agendas, capturing meeting minutes, documenting decisions and ensuring appropriate follow-up for action items.
  • Ensure alignment within project teams, relevant communication with managers and leadership teams.
  • Drive collaboration, cooperation and communication across cross-functional teams to achieve stated goals.
  • Assist with execution of project plans within a team environment. Institute a development pathway with decision stage gates.
  • Interface with Finance to coordinate and improve accuracy of budgeting, accounting and forecasting for program related activities. Ensure detail on investments to be made across the program and spend vs. forecast are aligned.
  • Maintain close relationships with projects teams and departments to ensure that all critical parties are aware of project activity, issues and contingencies.
  • Assist in facilitating information flow between team members; strive to identify and resolve issues arising on the project.
  • Develop and implement communication tools that enhance information exchange and stimulate creative project interactions.

Experience, Education and Specialized Knowledge and Skills

  • Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
  • Key understanding of the drug development process and key functional responsibilities involved in the development of a drug candidate from IND enabling studies through to IND/CTA and BLA/NDA/MAA filings. Commercial launch experience a plus.
  • Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
  • Strong knowledge of project management software/tools including but not limited to the Microsoft suite of products, Gantt chart tools, other technical tools as applicable.
  • Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
  • Strong ability to communicate in English, verbally and nonverbally.
  • Bachelor’s degree in science, business or equivalent.
  • 7+ years’ experience in scientific project leadership or program management in the biotechnology/pharmaceutical industry.

Travel: Regular travel between the Gamida Cell facilities in Jerusalem and Kiryat Gat. Minimal international travel required, once travel resumes

Reports to:  Chief Medical officer 

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

Senior Director, Global Health Economics & Outcomes Research

USA
Read More

Gamida Cell is a clinical-stage biopharmaceutical company committed to developing novel cell therapies with the potential to cure difficult-to-treat cancers and rare, serious hematologic diseases. We are leveraging our proprietary nicotinamide-based cell expansion technology, or NAM technology, to develop product candidates designed to address the limitations of current therapies. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy in development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution. Omidubicel is currently being evaluated in an international, multi-center, randomized Phase 3 study in patients with high-risk blood cancers.

The Senior Director, Global Health Economics & Outcomes Research (HEOR) will play a critical and significant role in the growth of Gamida Cell as an organization and in the successful commercialization of its novel cellular therapy pipeline products. The HEOR lead will work at a global level to lead the development of HEOR research strategies and plans to support optimal market access for the therapies. In addition, they will support the development and submission of in-country Health Technology Assessment (HTA) and Pricing & Reimbursement (P&R) submissions. The person in this leadership position will also represent HEOR at internal review groups and in front of Executive leadership as well as to our external Market Access customers.

KEY RESPONSIBILITIES

The Sr. Director of Global HEOR will:

  • Develop global HEOR strategies including analyses of currently available data and generate plans to fill identified gaps.
  • Develop HEOR engagement strategies specific to payers and stakeholders in the US, Europe and Israel.
  • Manage relationships with external consultants to ensure timely completion of high-quality projects aligned to strategic objectives.
  • Design, implement, and manage HEOR projects, including but not limited to:
      • Retrospective database analyses o Heath economic models.
      • Budget impact models.
      • Chart reviews.
      • Real world evidence o Literature searches and systematic review.
  • Support development and maintenance of global value dossiers.
  • Identify appropriate data sources to support the projects described above.
  • Conduct economic analyses and/or conduct detailed reviews of existing analyses.
  • Work with KOLs to implement HEOR plans.
  • Communicate study plans, study methods and results to internal teams.
  • Present health outcomes research findings at scientific congresses and participate in the development and writing of manuscripts for publication in peer-reviewed journals.
  • Build strong relationships with internal stakeholders and ensure continuous and consistent communication with key internal partners on HEOR projects.
  • Represent HEOR on cross-functional internal teams.
  • Remain current on HEOR data sources and analytical methods.
  • Work with clinical development teams to identify appropriate trial endpoints for products in development.
  • Work closely with US and Israeli colleagues, and external consultants to develop strategies specific to US, European or Israeli payers and stakeholders.
  • Lead consultancy support in the development of in-country HTA and P&R dossiers.
  • Identify appropriate US, European or Israeli data sources.
  • Other projects and activities as assigned.

QUALIFICATIONS

  • Proven expertise in Health Economics / Outcomes Research.
  • At least 5 years pharma/biotech experience with HEOR strategy and implementation in US and Europe.
  • Understanding market access and how HEOR evidence supports access decisions.
  • Country and regional/global experience within a pharmaceutical company or consultancy
  • Hematology/oncology experience required.
  • Cell therapy, rare disease, orphan or ultra-orphan product experience highly desirable.
  • Life sciences degree; post-graduate degree preferred.
  • Excellent verbal and written communication skills.
  • Excellent analytical skills, including in-depth knowledge of health economic modeling.
  • Experience in managing multiple projects across a variety of health outcomes methodologies and therapeutic areas.
  • Solid understanding of epidemiology and biostatistics.

EDUCATION

  • Minimum masters degree, scientific or technical area.
  • Preferred advanced degree related to health economics and/or outcomes research.
  • Fluent in English, written and oral.

ADDITIONAL

  • Travel: Up to 40%, once travel resumes

Vice President, Medical Affairs

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. Omidubicel is currently being evaluated in an international, multi-center, randomized Phase 3 study in patients with high-risk blood cancers, and positive topline data from the study were reported in May 2020.

General Scope and Summary

Gamida Cell is at an exciting inflection point for the business, preparing for a successful launch of its lead product, omidubicel, and seeks a Vice President, Medical Affairs to develop and lead a highly efficient and integrated medical function, including scientific evidence generation and scientific information exchange with all key stakeholders.

Reporting to the Chief Medical Officer, this individual will be a member of the Clinical Leadership Team and a key partner internally with the global Commercial, Market Access, Clinical, and Communications teams, as well as externally with key opinion leaders, healthcare professionals and payors.

Over time, the VP Medical Affairs will build a team of internally and externally facing professionals, including medical science liaisons and MDs. This position will have a strong outward-facing presence in the U.S. and global KOL community and requires domestic and international travel.

The individual will be passionate about the portfolio, have high energy in daily duties, and be optimistic about Gamida Cell’s trajectory and goals.

The Vice President of Medical Affairs will build and maintain a strong, world-class organization that is aligned around global medical strategies and ensures execution of strategy through the management of complex relationships with multiple stakeholders both within and outside of the company.

Roles and Responsibilities

  • Develop and lead medical affairs strategies including medical communications, engagement with opinion leaders, investigator-led research, data dissemination, and external collaborations.
  • Lead the development of medical affairs activities including publication planning, medical advisory boards, educational programs, conferences, and responding to requests for medical information.
  • Provide medical expertise and collaborate in the development of strategies for commercial, market access, business development, and public relations activities.
  • Establish professional relationships with the medical community and exchange scientific knowledge with global and regional key opinion leaders.
  • Partner with Commercial to ensure timely, accurate, and compliant preparation and review of promotional and educational material.
  • Establish and execute a strategic publication and congress plan; work with internal colleagues to develop key messages on unmet need, mechanism of action, target product profile, and other materials.

Experience, Education and Specialized Knowledge and Skills

  • Academic Training: Doctoral degree in clinical specialty required (M.D., Ph.D., Pharm D.) with experience in hematology/oncology and/or bone marrow transplant.
  • Industry Experience: A minimum of 10 years of experience in the pharmaceutical or biotech industries.
  • Medical Affairs Experience: Demonstrated ability to develop scientific plans in support of end game product differentiation, customer needs, and clinical practice patterns that lead to prescribing. Experience and demonstrated track record in a medical affairs leadership role in the US, marketing and commercially savvy and robust understanding of late stage development projects and regulatory space. Understanding of evolving environmental and market access issues.
  • Product Launch Experience: Demonstrated record of product launches in the US and ability to bring strategic insight to commercialization plans. Global launch experience ideal but not a must.
  • Leadership Experience: Visionary and entrepreneurial, with experience in building, leading, driving and engaging a successful team. Strong executive presence as equally as a hands-on mind-set. Outstanding communication skills and ability to work effectively in a diverse global corporate environment.

Travel: 30%, once travel resumes

Reports to: Chief Medical Officer

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

Vice President, Marketing and Account Management

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. Omidubicel is currently being evaluated in an international, multi-center, randomized Phase 3 study in patients with high-risk blood cancers, and positive topline data from the study were reported in May 2020.

General Scope and Summary

Gamida Cell is at an exciting inflection point for the business, preparing for a successful launch of its lead product, omidubicel, and seeks a Vice President, Marketing and Account Management to develop and lead a highly efficient and effective marketing and account management function to successfully enable availability to omidubicel as well as build the foundation of our marketing and account management capabilities to ensure the success of future products.

Roles and Responsibilities

  • Leading the omidubicel brand essence development and preparing omidubicel for launch in the U.S.
  • Leading the development of the commercial strategy for the NAM platform therapies, including omidubicel, GDA-201 and future therapies
  • Serving as the cross functional launch readiness lead for omidubicel and future launches
  • Leading the development of the brand strategy and overseeing the marketing team implementation
  • Developing the account management team including defining strategy, roles and responsibilities, policies, processes/procedures, tools and technologies, and incentives
  • Leading the implementation of the cross-functional launch plan
  • Representing commercial on the regulatory team, including label development and finalization
  • Supporting the professional alliance team with the development of the thought leader interaction plan, integrated professional society/advocacy plans and congress planning activities
  • Leading the government affairs initiatives for Gamida Cell
  • Developing the commercial training plan and providing oversight for implementation
  • Partnering with market access and medical affairs for the development of the health economics strategy and analyses
  • Partnering with market access to align the market access strategy with the overall commercial strategy
  • Partnering with market access to finalize the strategy and operations for the Gamida assist team
  • Achieving the commercial goals as defined by the metrics in the launch score card
  • Overseeing the establishment of the account management team objectives and incentive compensation/bonus structure
  • Key partnering with commercial operations and IT in the development of the business requirements for account management tools and systems implementation
  • Managing the budget associated with marketing, account management team, and any commercial launch related expenses
  • Key partnering with commercial analytics in market research, forecasting, performance tracking and business reviews
  • Building a culture of compliance to ensure that all commercial activities are fully compliant with company policies and legal and regulatory guidelines
  • Coaching, training, and mentoring team members; sourcing key talent internally and externally to maintain a bench of strong leaders
  • Contributing as a critical stakeholder to cross-functional partners strategic plans

Experience, Education and Specialized Knowledge and Skills

Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to set a commercial vision and strategy for products and functional teams at the corporate level and translate and communicate with clarity into actionable plans; excellent analytical skills and an ability to communicate complex issues in a simple way to executives and to orchestrate plans to resolve issues and mitigate risks.

  • 15+ years related experience in the biotechnology industry with a proven, consistent history of high performance in a broad range of leadership roles of increasing responsibility
  • 8+ years of progressive sales leadership experience with demonstrated results as a Marketing and Field Force leader
  • B.A./B.S. degree required. Advanced degree in Business, Marketing or Life Sciences preferred
  • Significant product launch experience in a marketing, sales or account management leadership roles
  • Demonstrates exceptional leadership, management and communication skills to inspire sales and account management teams to achieve high levels of performance
  • Strong executive presence with the ability to set vision and strategy for sales and account management at the national level and lead the organization through large scale change
  • Must have experience building out and leading new teams and functions
  • Demonstrated success leading teams of account managers responsible for securing product access and pull through in hospitals / health systems is pivotal to the role
  • Expert level knowledge of pricing and reimbursement and market access strategies across therapeutic treatment settings.
  • Brand marketing and national/regional payer account management experience is highly desired
  • Strong team player who has a customer service approach and is solution oriented
  • Attention to detail and the ability to work individually and across a multi-disciplinary leadership team, as well as with multiple external partners and vendors
  • Possesses strong written and verbal communication skills

Travel: ~50% Travel once travel resumes

Reports to: Chief Operating and Chief Commercial Officer

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

Director, Regulatory Affairs

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. Omidubicel is currently being evaluated in an international, multi-center, randomized Phase 3 study in patients with high-risk blood cancers, and positive topline data from the study were reported in May 2020.

General Scope and Summary

Gamida Cell is looking for a Regulatory Affairs leader to join the team for directing innovative global regulatory strategies for product development and approval. Responsible for defining strategies for meeting and keeping post approval compliance. Responsible for regulatory documents, submissions, and compliance issues. Represent the company with domestic and international regulatory authorities, contractors and corporate partners. Provide regulatory support for various departments, projects, and teams/committees. Provide mentorship and leadership to others, both direct reports as well as cross-functionally.

Roles and Responsibilities

  • Effectively establish, resource and manage the company’s regulatory affairs function in USA, providing strong leadership and focus.
  • Develop and implement appropriate regulatory labelling strategies to support marketing applications for U.S., EU and other RoW territories of the company’s development candidates.
  • Ensure that the company’s products are developed to be regionally compliant and that they remain in regulatory compliance; define strategies to mitigate risks.
  • Keep abreast of new FDA regulatory requirements (as well as those from other key international regulatory authorities) and anticipate their future impact on Gamida Cell.
  • Develop and maintain strong relationships with health authorities/regulators, contractors and corporate partners while negotiating on behalf of Gamida Cell.
  • Promote a positive work environment by communicating a clear direction on goals, provide support to other areas, and work in a fashion consistent with Gamida Cells’ values.
  • Play a substantive role in the preparation of submission-relevant documents relating to Gamida’s development activities, including BLA and MAA submissions, label extensions, post-approval regulatory obligations, etc.
  • Play a key role in providing guidance and advice to product development project teams with respect to regulatory requirements and trends affecting corporate strategy, programs, business development and processes.
  • Assess compliance of CMC documents with current guidelines and regulations. Recommend strategies to achieve such compliance; assess impact of proposed CMC changes to licenses or clinical trial applications.
  • Oversee regulatory promotional compliance.
  • Provide input to Executive Management team(s).
  • Actively participate in and contribute to outside relevant conferences, including organizing and delivering presentations.

Experience, Education and Specialized Knowledge and Skills

  • BS degree in sciences, preferably life sciences.
  • 8 years pharmaceutical/biotechnology industry experience with technical management experience.
  • Minimum of 6 years in RA, with in-depth knowledge of applicable regulations.
  • Experience in interpretation of regulations, guidelines, policy statements, etc.
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
  • Experience in interfacing with relevant regulatory authorities.
  • Foster effective, positive interactions with regulatory agencies, and corporate partners.
  • Ability to lead, influence and represent project teams, committees, external meeting etc. to attain group goals.
  • Demonstrate excellent leadership, organization and communication skills.
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
  • Strong sensitivity for a multicultural/multinational environment.
  • Ability to guide, train, mentor, supervise and prioritize workload of direct reports. 

Travel: 20%, once travel resumes

Reports to: Chief Regulatory Affairs and Quality Assurance Office

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

Program 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. Omidubicel is currently being evaluated in an international, multi-center, randomized Phase 3 study in patients with high-risk blood cancers, and positive topline data from the study were reported in May 2020.

General Scope and Summary

This is an exciting opportunity to work in a multi-faceted program management role.  The Program Manager will provide project management support to the cross-functional program teams to successfully support the progression of drug development projects in all phases. These responsibilities will include managing program plans, timelines, critical path activities and operations support at all levels to ensure seamless execution of the program. The Program Manager provides support and facilitates proactive planning, issues identification and risk mitigation discussions with the cross-functional program teams and Executive Leadership to ensure successful and timely execution of programs. The Program Manager will ensure that the program strategy is clearly integrated into the project budget and operational plans. Initially the key responsibilities will be for the omidubicel program and other earlier programs, as applicable.

Roles and Responsibilities

  • Develop and maintain detailed project plans, monitors progress to timelines and budget, supports resource management, risk management and change management to deliver against agreed strategic objectives.
  • Establish cross-functional team and coordinate meetings to support research, development, clinical, manufacturing, and regulatory activities, including setting agendas, capturing meeting minutes, documenting decisions and ensuring appropriate follow-up for action items.
  • Ensure alignment within project teams, relevant communication with managers and leadership teams.
  • Drive collaboration, cooperation and communication across cross-functional teams to achieve stated goals.
  • Assist with execution of project plans within a team environment. Institute a development pathway with decision stage gates.
  • Interface with Finance to coordinate and improve accuracy of budgeting, accounting and forecasting for program related activities. Ensure detail on investments to be made across the program and spend vs. forecast are aligned.
  • Maintain close relationships with projects teams and departments to ensure that all critical parties are aware of project activity, issues and contingencies.
  • Assist in facilitating information flow between team members; strive to identify and resolve issues arising on the project.
  • Develop and implement communication tools that enhance information exchange and stimulate creative project interactions.

Experience, Education and Specialized Knowledge and Skills

  • Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
  • Key understanding of the drug development process and key functional responsibilities involved in the development of a drug candidate from IND enabling studies through to IND/CTA and BLA/NDA/MAA filings. Commercial launch experience a plus.
  • Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
  • Strong knowledge of project management software/tools including but not limited to the Microsoft suite of products, Gantt chart tools, other technical tools as applicable.
  • Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
  • Strong ability to communicate in English, verbally and nonverbally.
  • Bachelor’s degree in science, business or equivalent.
  • 7+ years’ experience in scientific project leadership or program management in the biotechnology/pharmaceutical industry.

Travel: Regular travel between the Gamida Cell facilities in Jerusalem and Kiryat Gat. Minimal international travel required, once travel resumes

Reports to:  Chief Medical officer 

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