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 firstname.lastname@example.org.