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, Training

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 primary and secondary endpoint data reported in 2020.

General Scope and Summary

The Senior Director, Training is a key role focused on ensuring the successful launch of omidubicel along with future therapies. This individual will be responsible for developing, maintaining, and delivering of disease, therapy, account management skills, market knowledge and operations/logistics training intended for members of the commercial organization. This individual will partner with and provide a conduit to all cross functional commercial teams in identifying, building and executing training to meet the development needs of the commercial organization during market development, launch and post-launch phases and will report to the Vice President, Marketing and Account Management.

Roles and Responsibilities

  • Lead the commercial training and development and manage training budget.
  • Develop, maintain, and execute training programs, and on- board new employees through advanced training for the commercial organization.
  • Maintain subject matter expertise for disease states, products and therapeutic areas aligned with Gamida Cell portfolio and account management.
  • Coordinate with legal, medical and regulatory colleagues to ensure accuracy of medical content and compliance with promotional policies for training materials.
  • Collaborate with the marketing, account management, and market access teams to build training initiatives that support the execution of tactics aligned with brand strategy and coordinate the rollout of promotional materials.
  • Lead collaboration with cross functional teams (marketing, market access, medical affairs) to provide disease state, product and therapeutic training and functional training as required.
  • Identify, contract, and manage vendors and oversee project management during development of training content.
  • Assume responsibility for designated in-house training meetings to include planning, logistics management, vendor monitoring, and participant conduct.
  • Lead the planning, designing, and execution of training offerings at national meetings, POA meetings and launch meetings.
  • Ensure training documentation through oversight and maintenance of the commercial learning management system (LMS).
  • Establish and maintain the standards for training materials including product and learning system modules.
  • Develop and maintain facilitation skills/advanced selling skills expertise in support of training content delivery.
  • Collaborate effectively with all cross-functional partners including but not limited to legal, HR, quality, etc. to create a forum of best practices, consistency of learning materials, alignment on Company approach to learning, etc.

Experience, Education and Specialized Knowledge and Skills

  • 10+ years industry experience with 5-7 years of hematology/oncology/biotech training experience: launch experience required, knowledge of cell and gene therapy preferred.
  • B.A./B.S. required: Advanced degree in business, marketing, or life sciences preferred.
  • Exceptional presentation, facilitation, and written communication skills.
  • Demonstrated effectiveness in organization and planning skills.
  • Demonstrated experience in leading strategically, driving performance and fostering collaboration within a cross functional environment.
  • Ability to rapidly identify issues and effectively implement solutions.
  • Committed to making a positive contribution to the company and establish trust and credibility with team members.
  • Leader training in DiSC, Situational Leadership, Talent Profiler, Crucial Conversations preferred.
  • Expertise with technology platforms (e.g. iPAD, LMS, Vault) and programs (e.g. MS PowerPoint, MS Word, MS Excel, Adobe Professional) is highly desirable.
  • Experience using a variety of modalities for learning including traditional classroom, online, self-study, workshops, AV/VR, etc. to create effective and efficient manners to deliver content.
  • Achieves organizational focus while valuing diverse and opposing views among multi-cultural teams.

Travel: 25-50% once travel resumes

Reports to: Vice President, Marketing and Account Management

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

Director, Marketing

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 primary and secondary endpoint data reported in 2020.

General Scope and Summary

The Director, Marketing is a key member of the Marketing and Account Management team focused on ensuring the successful launch of omidubicel. The Director, Marketing will partner cross functionally to assist in developing the overall marketing launch strategy and tactics.  This role will ensure tactical execution during market development, launch and post-launch phases and will report to the Senior Director, Marketing.

Roles and Responsibilities

  • Maximize the commercial potential of omidubicel through the execution of strategic/tactical marketing plans and innovative marketing solutions to drive awareness and uptake.
  • Drive strong communications plan to reinforce positioning, brand essence, and messaging.
  • Develop marketing strategies and messages for multiple stakeholders including transplanters, transplant coordinators, nurses, stem cell labs, and patients. Partner with legal, medical and regulatory for review and approval of all materials prior to distribution.
  • Partner with market access to deliver market access materials (payer deck, billing and coding guide, etc.) to ensure consistency of branding and messaging.
  • Partner with:
    • Market access to provide input into value proposition
    • Medical affairs to incorporate insights into launch planning
    • Professional alliance team to support commercial KOL engagement strategy and congress planning activities
    • Commercial analytics to develop and track brand insights
    • Training team to develop training tools
    • Account management leaders and team for field communications
    • Oversee external partners and manage respective budget line items

Experience, Education and Specialized Knowledge and Skills

  • 7+ years industry experience with 3-5 years of hematology/oncology biotech/pharmaceutical marketing/equivalent experience: launch experience required, knowledge of cell and gene therapy preferred.
  • B.A./B.S. required: Advanced degree in business, marketing, or life sciences preferred.
  • Demonstrated experience in leading strategically, driving performance and fostering collaboration within a cross functional environment.
  • Ability to rapidly identify issues and effectively implement solutions.
  • 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: 25-50% once travel resumes

Reports to: Senior Director, Marketing

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

Senior Director, U.S. 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 primary and secondary endpoint data reported in 2020.

General Scope and Summary

The role of the Senior Director, U.S. Medical Affairs is to ensure that Gamida Cell can maintain a leadership position in the areas of cellular therapy and transplantation. This is a key strategic leadership position that will assess and understand the landscape, work with internal and external experts to determine the unmet need in these diseases, evaluate external best-practices, work across several functions to develop a prioritized strategy and action plan for successful execution of Medical Affairs and business goals. This position will also be responsible for hiring and managing the field based MSL team.

In addition, this position will work closely with internal partners in Research and Clinical Development to help shape asset strategy and to advance other pipeline assets in current and future areas of focus for the company.

Roles and Responsibilities

  • Co-develop and implement the medical affairs plan, scientific communication, and publication programs with approved budgets.
  • Responsible for recruiting and leading the field based medical team (MSLs and CBU specialists) and managing these direct reports.
  • Develop a deep understanding of the therapeutic landscape including internal investigational products, established and emerging competition, key changes to market dynamics, and remaining unmet need.
  • Provide medical expertise to medical affairs and cross-functional teams regarding development of educational materials, monitoring of published literature, addressing, and resolving issues related to products under their responsibility and provide medical review of promotional materials, sales training, payer presentations, and speaker training.
  • Work closely with Gamida Cell internal departments – research and development, clinical development, business development, commercial etc. to develop and implement strategies that enhance Gamida Cell’s leadership position in cellular therapy over the long term.
  • Responsible for the design, planning and execution of an overall medical strategy including creating, organizing and leading Advisory Boards.
  • Impeccable customer focus: both internal and external.
  • Spearhead efforts for the recruitment, development and performance management of appropriate team members in medical affairs and manage performance and development planning of all direct reports including adherence to all training and compliance policies.
  • Chair the scientific review meetings of investigator initiated and Phase IV studies and be responsible medically for the clinical studies under their direction as well as directing the design, conduct, analysis and reporting of Phase IV US medical affairs clinical trials or registries. This also includes providing key strategic US input for clinical development plans (Phase I – IV) and reviewing and co-approving clinical study protocols.
  • Accountable for compliant business practices

Experience, Education and Specialized Knowledge and Skills

  • Ph.D., Pharm.D., M.D. or equivalent with at least 10 years of industry experience in medical affairs.
  • Experience working with hematology and oncology products in the industry setting. Experience in cellular therapy is preferred.
  • Proven ability in leading both medical affairs team members and cross functional project teams including contractors and consultants as well as performing successfully under stringent timelines and with competing priorities.
  • Demonstrated track record of creativity and innovation and ability to move quickly to action.
  • Experience in the development and execution of clinical trials preferred. Ability to develop interventional, non-interventional clinical trial protocols, and registries a plus. Understanding of real-world evidence data sources and methods and payer environment a plus.
  • Significant familiarity with drug discovery, development, and commercialization process
  • Strong clinical insight and understanding of translational medicine and/or biomarkers.
  • Ability to present and discuss complex clinical, medical, biological, or translational data.
  • Implement successful clinical strategies and programs for investigator-initiated research and experience managing an IIR portfolio.
  • Strong business acumen, vision, and robust analytical, negotiation and influencing skills.
  • Effective communicator with strong oral and written communications skills.

Travel: Approximately 30-40% travel is required, once travel resumes

Reports to: Vice President, Medical Affairs

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

Director, Payer Access & Reimbursement

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 was evaluated in an international, multi-center, randomized Phase 3 study in patients with high-risk blood cancers, and positive primary and secondary endpoint data reported in 2020.

General Scope and Summary

The Director, Payer Access & Reimbursement is a key role focused on ensuring that patients have timely access to therapy. The Director, Payer Access & Reimbursement will operationalize the overall payer and hospital administrator strategy.  The primary objective of the role is to educate payers on Gamida Cell’s products, support appropriate patient access to care, and develop and implement access strategy.  This role will also ensure hospital administrators are aware of appropriate coverage policies and how to appropriately access Gamida Cell’s therapies in the post launch phase.

Roles and Responsibilities

  • Identify, develop, and manage strategic relationships with national and regional payers within assigned region.
  • Build proactive relationships with organizations/KOLs whose experience and expertise are relied on by payers.
  • Assess payer and policy landscape to understand potential coverage of Gamida Cell’s products for Commercial, Medicare and Medicaid patients.
  • Understand payer requirements and hospital reimbursement for cell therapies administered in the inpatient setting.
  • Develop and implement account level business plans.
  • Responsible and accountable for the successful implementation within region of the strategic and tactical market access plan.
  • Implement approved pre-launch payer education plan to ensure awareness of Gamida Cell’s products.
  • Present / provide approved product education and health economic information to key customers and communicate the value proposition of Gamida Cell’s products.
  • Partner with medical affairs and market access team to address clinical and outcomes concerns from payers.
  • Obtain coverage for Gamida Cell’s products within assigned accounts.
  • Identify and mitigate potential challenges that may hinder access.
  • Work with Gamida Cell Assist to ensure understanding of payer coverage policy and requirements and assist with any coverage questions.
  • Post launch, partner with field account management team to provide education on respective payers and to address any questions/concerns that arise.
  • Establish critical relationships with a variety of stakeholders within their geography: key transplant centers, Medicare CMDs, health plan medical directors and state Medicaid directors.

Experience, Education and Specialized Knowledge and Skills

  • Demonstrated successful experience with National and Regional payers (5-7 years minimum); 10+ years total biotech/pharmaceutical experience in a commercial setting.
  • Sustained track record of access and reimbursement achievement in cell therapy, gene therapy, or hematology/oncology.
  • Knowledge of medical benefit and/or inpatient economics preferred.
  • Excellent strategic and business acumen skills, with demonstrated ability to successfully partner with payers.
  • Strong ability to work collaboratively and cross-functionally to ensure goals are achieved.
  • Possess a willingness and ability to work hands-on and with a sense of urgency, in a fast-paced, entrepreneurial environment.
  • Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences.
  • Proven ability to think strategically and prioritize.
  • Exceptional problem-solving skills.
  • Exhibits initiative, flexibility, tenacity, and dependability.
  • A./B.S. degree required; Master’s Degree a plus but not required.

Travel: 50% travel, once travel resumes

Reports to: Senior Director, Payer Access and Reimbursement

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

Supply Chain Manager

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 was being being evaluated in an international, multi-center, randomized Phase 3 study in patients with high-risk blood cancers, and positive primary and secondary endpoint data reported in 2020.

General Scope and Summary

The Supply Chain Manager is part of the Commercial Supply Chain Operations team.  This role is responsible for supporting Gamida Cell commercial operations by managing supply chain execution, activities and responsibilities related to the safe and timely delivery of product(s) to the US commercial market through coordination with manufacturing sites, Gamida Cell Assist and other third parties. Developing and strategically planning logistics, integrations, transportation, and order management solutions that address the needs for the distribution of final product in the US and internationally.

Direct, optimize and coordinate full order cycle; end to end process from cell order through delivery to patient. Liaise and negotiate with suppliers, contract manufacturer(s). Keep track of quality, delivery times, transport costs and efficiency. Resolve any arising problems or complaints. Coach and train Supply Chain team members.

Roles and Responsibilities

  • Change of Custody/Change of Identity (COC/COI) – Support compliant execution of the COC/COI of the product(s), deviation management, reconciliation for all COC/COI related events, including SOP’s and other documentation according to the relevant regulations.
  • Build end to end supply chain process flow to identify areas for process improvement.
  • Management and logistics of sourcing the starting material, Cord Blood Unit (CBU).
  • Evaluate and implement business systems for future automation of manual processes.
  • Product Logistics – transportation, provision of packaging, temperature compliance, track and trace and external COC/COI execution.
  • Order Management – Support designing, maintaining, and managing the operating model order to cash cycle and distribution system.
  • Scheduling and capacity – Support managing the scheduling planning/system to ensure adherence to schedule and the highest utilization of capacity.
  • Risk mitigation analytics and management.
  • Build and manage logistics operations for optimal quality, safety, environmental sustainability, cost-effectiveness, and asset utilization. Coordinate manufacturing plans and evaluate supply chain redundancy needs, ensuring that necessary product manufacturing and distribution backup resources are in place to avoid failure of supply or distribution to the marketplace in the event of a supply chain upset.
  • Manage the order management, scheduling, and logistics process for product packaging and shipments.
  • Develop, implement, manage, and maintain robust inbound & outbound cold chain logistics processes while maintaining high value product integrity and chain of custody/chain of identity.
  • Provide logistical support & expertise product launch and product geographical expansion launches both within the U.S. and internationally.
  • Support shipping and transport validation/qualification.
  • Manage and support root cause analysis and implementation of corrective actions for logistics deviations and exceptions.
  • Work to investigation and resolve international trade compliance issues.
  • Work collaboratively with both internal & external partners to achieve business goals.
  • Mentor, coach, & develop supply chain team members. as well as other cross functional team members who are new to the field.

Experience, Education and Specialized Knowledge and Skills

  • Bachelor’s degree in a related field.
  • Minimum of 5 years logistics and supply chain experience is required, ideally in the cell and gene therapy industry and in a complex manufacturing/supply environment with experience in cold chain logistics and good distribution practices.
  • 2 years project management experience with knowledge of current PM best practices & tools.
  • Understanding of ERP systems as well as strong computer skills and advanced skills in Excel and PowerPoint is necessary.
  • Hands on experience in supply chain operations, logistics, materials management, warehouse/ physical distribution, and customer order fulfillment is required.
  • Must have global operations experience, import / export operations, working knowledge of regulatory, drug licensing, and operating requirements in a global market.
  • Must have experience with global supplier relationship management, contract management & compliance, control, and oversight of contractor / supplier performance.
  • Demonstrated ability to build trust/effective relationships/partnerships with peers & stakeholders.
  • Effective communication, presentation, decision making, influencing and negotiation skills.
  • Excellent people t skills with multicultural background and organizational capability.
  • Extensive acumen in problem solving, managing priorities, commitment to quality & safety.
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
  • Ability to navigate and be successful in a fast-paced, work environment.
  • A passion for addressing the critical unmet medical needs of patients.
  • Willingness to embrace/demonstrate the principles of the Gamida Cell culture and values.

Reports to: Director, U.S. Commercial Supply Chain Operations

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.

Senior Director, Training

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 primary and secondary endpoint data reported in 2020.

General Scope and Summary

The Senior Director, Training is a key role focused on ensuring the successful launch of omidubicel along with future therapies. This individual will be responsible for developing, maintaining, and delivering of disease, therapy, account management skills, market knowledge and operations/logistics training intended for members of the commercial organization. This individual will partner with and provide a conduit to all cross functional commercial teams in identifying, building and executing training to meet the development needs of the commercial organization during market development, launch and post-launch phases and will report to the Vice President, Marketing and Account Management.

Roles and Responsibilities

  • Lead the commercial training and development and manage training budget.
  • Develop, maintain, and execute training programs, and on- board new employees through advanced training for the commercial organization.
  • Maintain subject matter expertise for disease states, products and therapeutic areas aligned with Gamida Cell portfolio and account management.
  • Coordinate with legal, medical and regulatory colleagues to ensure accuracy of medical content and compliance with promotional policies for training materials.
  • Collaborate with the marketing, account management, and market access teams to build training initiatives that support the execution of tactics aligned with brand strategy and coordinate the rollout of promotional materials.
  • Lead collaboration with cross functional teams (marketing, market access, medical affairs) to provide disease state, product and therapeutic training and functional training as required.
  • Identify, contract, and manage vendors and oversee project management during development of training content.
  • Assume responsibility for designated in-house training meetings to include planning, logistics management, vendor monitoring, and participant conduct.
  • Lead the planning, designing, and execution of training offerings at national meetings, POA meetings and launch meetings.
  • Ensure training documentation through oversight and maintenance of the commercial learning management system (LMS).
  • Establish and maintain the standards for training materials including product and learning system modules.
  • Develop and maintain facilitation skills/advanced selling skills expertise in support of training content delivery.
  • Collaborate effectively with all cross-functional partners including but not limited to legal, HR, quality, etc. to create a forum of best practices, consistency of learning materials, alignment on Company approach to learning, etc.

Experience, Education and Specialized Knowledge and Skills

  • 10+ years industry experience with 5-7 years of hematology/oncology/biotech training experience: launch experience required, knowledge of cell and gene therapy preferred.
  • B.A./B.S. required: Advanced degree in business, marketing, or life sciences preferred.
  • Exceptional presentation, facilitation, and written communication skills.
  • Demonstrated effectiveness in organization and planning skills.
  • Demonstrated experience in leading strategically, driving performance and fostering collaboration within a cross functional environment.
  • Ability to rapidly identify issues and effectively implement solutions.
  • Committed to making a positive contribution to the company and establish trust and credibility with team members.
  • Leader training in DiSC, Situational Leadership, Talent Profiler, Crucial Conversations preferred.
  • Expertise with technology platforms (e.g. iPAD, LMS, Vault) and programs (e.g. MS PowerPoint, MS Word, MS Excel, Adobe Professional) is highly desirable.
  • Experience using a variety of modalities for learning including traditional classroom, online, self-study, workshops, AV/VR, etc. to create effective and efficient manners to deliver content.
  • Achieves organizational focus while valuing diverse and opposing views among multi-cultural teams.

Travel: 25-50% once travel resumes

Reports to: Vice President, Marketing and Account Management

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

Director, Marketing

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 primary and secondary endpoint data reported in 2020.

General Scope and Summary

The Director, Marketing is a key member of the Marketing and Account Management team focused on ensuring the successful launch of omidubicel. The Director, Marketing will partner cross functionally to assist in developing the overall marketing launch strategy and tactics.  This role will ensure tactical execution during market development, launch and post-launch phases and will report to the Senior Director, Marketing.

Roles and Responsibilities

  • Maximize the commercial potential of omidubicel through the execution of strategic/tactical marketing plans and innovative marketing solutions to drive awareness and uptake.
  • Drive strong communications plan to reinforce positioning, brand essence, and messaging.
  • Develop marketing strategies and messages for multiple stakeholders including transplanters, transplant coordinators, nurses, stem cell labs, and patients. Partner with legal, medical and regulatory for review and approval of all materials prior to distribution.
  • Partner with market access to deliver market access materials (payer deck, billing and coding guide, etc.) to ensure consistency of branding and messaging.
  • Partner with:
    • Market access to provide input into value proposition
    • Medical affairs to incorporate insights into launch planning
    • Professional alliance team to support commercial KOL engagement strategy and congress planning activities
    • Commercial analytics to develop and track brand insights
    • Training team to develop training tools
    • Account management leaders and team for field communications
    • Oversee external partners and manage respective budget line items

Experience, Education and Specialized Knowledge and Skills

  • 7+ years industry experience with 3-5 years of hematology/oncology biotech/pharmaceutical marketing/equivalent experience: launch experience required, knowledge of cell and gene therapy preferred.
  • B.A./B.S. required: Advanced degree in business, marketing, or life sciences preferred.
  • Demonstrated experience in leading strategically, driving performance and fostering collaboration within a cross functional environment.
  • Ability to rapidly identify issues and effectively implement solutions.
  • 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: 25-50% once travel resumes

Reports to: Senior Director, Marketing

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

Senior Director, U.S. Medical 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 primary and secondary endpoint data reported in 2020.

General Scope and Summary

The role of the Senior Director, U.S. Medical Affairs is to ensure that Gamida Cell can maintain a leadership position in the areas of cellular therapy and transplantation. This is a key strategic leadership position that will assess and understand the landscape, work with internal and external experts to determine the unmet need in these diseases, evaluate external best-practices, work across several functions to develop a prioritized strategy and action plan for successful execution of Medical Affairs and business goals. This position will also be responsible for hiring and managing the field based MSL team.

In addition, this position will work closely with internal partners in Research and Clinical Development to help shape asset strategy and to advance other pipeline assets in current and future areas of focus for the company.

Roles and Responsibilities

  • Co-develop and implement the medical affairs plan, scientific communication, and publication programs with approved budgets.
  • Responsible for recruiting and leading the field based medical team (MSLs and CBU specialists) and managing these direct reports.
  • Develop a deep understanding of the therapeutic landscape including internal investigational products, established and emerging competition, key changes to market dynamics, and remaining unmet need.
  • Provide medical expertise to medical affairs and cross-functional teams regarding development of educational materials, monitoring of published literature, addressing, and resolving issues related to products under their responsibility and provide medical review of promotional materials, sales training, payer presentations, and speaker training.
  • Work closely with Gamida Cell internal departments – research and development, clinical development, business development, commercial etc. to develop and implement strategies that enhance Gamida Cell’s leadership position in cellular therapy over the long term.
  • Responsible for the design, planning and execution of an overall medical strategy including creating, organizing and leading Advisory Boards.
  • Impeccable customer focus: both internal and external.
  • Spearhead efforts for the recruitment, development and performance management of appropriate team members in medical affairs and manage performance and development planning of all direct reports including adherence to all training and compliance policies.
  • Chair the scientific review meetings of investigator initiated and Phase IV studies and be responsible medically for the clinical studies under their direction as well as directing the design, conduct, analysis and reporting of Phase IV US medical affairs clinical trials or registries. This also includes providing key strategic US input for clinical development plans (Phase I – IV) and reviewing and co-approving clinical study protocols.
  • Accountable for compliant business practices

Experience, Education and Specialized Knowledge and Skills

  • Ph.D., Pharm.D., M.D. or equivalent with at least 10 years of industry experience in medical affairs.
  • Experience working with hematology and oncology products in the industry setting. Experience in cellular therapy is preferred.
  • Proven ability in leading both medical affairs team members and cross functional project teams including contractors and consultants as well as performing successfully under stringent timelines and with competing priorities.
  • Demonstrated track record of creativity and innovation and ability to move quickly to action.
  • Experience in the development and execution of clinical trials preferred. Ability to develop interventional, non-interventional clinical trial protocols, and registries a plus. Understanding of real-world evidence data sources and methods and payer environment a plus.
  • Significant familiarity with drug discovery, development, and commercialization process
  • Strong clinical insight and understanding of translational medicine and/or biomarkers.
  • Ability to present and discuss complex clinical, medical, biological, or translational data.
  • Implement successful clinical strategies and programs for investigator-initiated research and experience managing an IIR portfolio.
  • Strong business acumen, vision, and robust analytical, negotiation and influencing skills.
  • Effective communicator with strong oral and written communications skills.

Travel: Approximately 30-40% travel is required, once travel resumes

Reports to: Vice President, Medical Affairs

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

Director, Payer Access & Reimbursement

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 was evaluated in an international, multi-center, randomized Phase 3 study in patients with high-risk blood cancers, and positive primary and secondary endpoint data reported in 2020.

General Scope and Summary

The Director, Payer Access & Reimbursement is a key role focused on ensuring that patients have timely access to therapy. The Director, Payer Access & Reimbursement will operationalize the overall payer and hospital administrator strategy.  The primary objective of the role is to educate payers on Gamida Cell’s products, support appropriate patient access to care, and develop and implement access strategy.  This role will also ensure hospital administrators are aware of appropriate coverage policies and how to appropriately access Gamida Cell’s therapies in the post launch phase.

Roles and Responsibilities

  • Identify, develop, and manage strategic relationships with national and regional payers within assigned region.
  • Build proactive relationships with organizations/KOLs whose experience and expertise are relied on by payers.
  • Assess payer and policy landscape to understand potential coverage of Gamida Cell’s products for Commercial, Medicare and Medicaid patients.
  • Understand payer requirements and hospital reimbursement for cell therapies administered in the inpatient setting.
  • Develop and implement account level business plans.
  • Responsible and accountable for the successful implementation within region of the strategic and tactical market access plan.
  • Implement approved pre-launch payer education plan to ensure awareness of Gamida Cell’s products.
  • Present / provide approved product education and health economic information to key customers and communicate the value proposition of Gamida Cell’s products.
  • Partner with medical affairs and market access team to address clinical and outcomes concerns from payers.
  • Obtain coverage for Gamida Cell’s products within assigned accounts.
  • Identify and mitigate potential challenges that may hinder access.
  • Work with Gamida Cell Assist to ensure understanding of payer coverage policy and requirements and assist with any coverage questions.
  • Post launch, partner with field account management team to provide education on respective payers and to address any questions/concerns that arise.
  • Establish critical relationships with a variety of stakeholders within their geography: key transplant centers, Medicare CMDs, health plan medical directors and state Medicaid directors.

Experience, Education and Specialized Knowledge and Skills

  • Demonstrated successful experience with National and Regional payers (5-7 years minimum); 10+ years total biotech/pharmaceutical experience in a commercial setting.
  • Sustained track record of access and reimbursement achievement in cell therapy, gene therapy, or hematology/oncology.
  • Knowledge of medical benefit and/or inpatient economics preferred.
  • Excellent strategic and business acumen skills, with demonstrated ability to successfully partner with payers.
  • Strong ability to work collaboratively and cross-functionally to ensure goals are achieved.
  • Possess a willingness and ability to work hands-on and with a sense of urgency, in a fast-paced, entrepreneurial environment.
  • Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences.
  • Proven ability to think strategically and prioritize.
  • Exceptional problem-solving skills.
  • Exhibits initiative, flexibility, tenacity, and dependability.
  • A./B.S. degree required; Master’s Degree a plus but not required.

Travel: 50% travel, once travel resumes

Reports to: Senior Director, Payer Access and Reimbursement

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

Supply Chain 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. Omidubicel was being being evaluated in an international, multi-center, randomized Phase 3 study in patients with high-risk blood cancers, and positive primary and secondary endpoint data reported in 2020.

General Scope and Summary

The Supply Chain Manager is part of the Commercial Supply Chain Operations team.  This role is responsible for supporting Gamida Cell commercial operations by managing supply chain execution, activities and responsibilities related to the safe and timely delivery of product(s) to the US commercial market through coordination with manufacturing sites, Gamida Cell Assist and other third parties. Developing and strategically planning logistics, integrations, transportation, and order management solutions that address the needs for the distribution of final product in the US and internationally.

Direct, optimize and coordinate full order cycle; end to end process from cell order through delivery to patient. Liaise and negotiate with suppliers, contract manufacturer(s). Keep track of quality, delivery times, transport costs and efficiency. Resolve any arising problems or complaints. Coach and train Supply Chain team members.

Roles and Responsibilities

  • Change of Custody/Change of Identity (COC/COI) – Support compliant execution of the COC/COI of the product(s), deviation management, reconciliation for all COC/COI related events, including SOP’s and other documentation according to the relevant regulations.
  • Build end to end supply chain process flow to identify areas for process improvement.
  • Management and logistics of sourcing the starting material, Cord Blood Unit (CBU).
  • Evaluate and implement business systems for future automation of manual processes.
  • Product Logistics – transportation, provision of packaging, temperature compliance, track and trace and external COC/COI execution.
  • Order Management – Support designing, maintaining, and managing the operating model order to cash cycle and distribution system.
  • Scheduling and capacity – Support managing the scheduling planning/system to ensure adherence to schedule and the highest utilization of capacity.
  • Risk mitigation analytics and management.
  • Build and manage logistics operations for optimal quality, safety, environmental sustainability, cost-effectiveness, and asset utilization. Coordinate manufacturing plans and evaluate supply chain redundancy needs, ensuring that necessary product manufacturing and distribution backup resources are in place to avoid failure of supply or distribution to the marketplace in the event of a supply chain upset.
  • Manage the order management, scheduling, and logistics process for product packaging and shipments.
  • Develop, implement, manage, and maintain robust inbound & outbound cold chain logistics processes while maintaining high value product integrity and chain of custody/chain of identity.
  • Provide logistical support & expertise product launch and product geographical expansion launches both within the U.S. and internationally.
  • Support shipping and transport validation/qualification.
  • Manage and support root cause analysis and implementation of corrective actions for logistics deviations and exceptions.
  • Work to investigation and resolve international trade compliance issues.
  • Work collaboratively with both internal & external partners to achieve business goals.
  • Mentor, coach, & develop supply chain team members. as well as other cross functional team members who are new to the field.

Experience, Education and Specialized Knowledge and Skills

  • Bachelor’s degree in a related field.
  • Minimum of 5 years logistics and supply chain experience is required, ideally in the cell and gene therapy industry and in a complex manufacturing/supply environment with experience in cold chain logistics and good distribution practices.
  • 2 years project management experience with knowledge of current PM best practices & tools.
  • Understanding of ERP systems as well as strong computer skills and advanced skills in Excel and PowerPoint is necessary.
  • Hands on experience in supply chain operations, logistics, materials management, warehouse/ physical distribution, and customer order fulfillment is required.
  • Must have global operations experience, import / export operations, working knowledge of regulatory, drug licensing, and operating requirements in a global market.
  • Must have experience with global supplier relationship management, contract management & compliance, control, and oversight of contractor / supplier performance.
  • Demonstrated ability to build trust/effective relationships/partnerships with peers & stakeholders.
  • Effective communication, presentation, decision making, influencing and negotiation skills.
  • Excellent people t skills with multicultural background and organizational capability.
  • Extensive acumen in problem solving, managing priorities, commitment to quality & safety.
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
  • Ability to navigate and be successful in a fast-paced, work environment.
  • A passion for addressing the critical unmet medical needs of patients.
  • Willingness to embrace/demonstrate the principles of the Gamida Cell culture and values.

Reports to: Director, U.S. Commercial Supply Chain Operations

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.