Director/Senior Director, Clinical Development
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
Working with cross-functional teams and external collaborators, the Medical Director will take a leadership role in the creation and execution of clinical development plans, medical oversight and interactions with investigators and other critical clinical stakeholders. This is a hands-on role, both involved with providing strategic insights to advance clinical programs while also being able to develop and execute well-defined plans all while leading within a cross-functional organization where our values in action are prioritized.
Roles and Responsibilities
- Development of new and ongoing clinical research programs including but not limited to:
- Design of clinical trials, including patient populations, standard of care, unmet need
- Clinical trial protocol development and protocol amendments
- Support investigator engagement and clinical site evaluation
- Medical support including clinical site training, eligibility questions, safety monitoring, data quality monitoring, regulatory interactions, patient recruitment and GCP
- Interpretation and summary of clinical outcomes
- Medical/translational education and messaging:
- Ongoing medical support and education to the Clinical team and other cross-functional teams
- Continued follow up of medical practices in the relevant fields, evolving parallel treatments, new indications, unmet needs and translational research
- Current understanding of clinical aspects of regulatory guidance and strategic approach
- Support to Commercial, Regulatory and Medical Affairs in subject matter expertise
- Preparation of position documents, presentations and publications
- Development of relationships with investigators, thought leaders and experts
Experience, Education and Specialized Knowledge and Skills
- MD preferred, or other high level clinical background.
- Experience in clinical development in heme/oncology required. Specific experience preferred: lymphoma, cell therapies.
- Excellent verbal and written communication skills in English; ability to communicate within a multi-cultural work environment.
- Good medical writing skills
- Familiarity with GCP principles and FDA/EMA regulatory guidelines for clinical development
- Team player, strong analytical skills and ability to work with minimal supervision, under pressure and meet deadlines.
- Good personal communication and interaction capabilities.
- Ability to lead and educate.
Travel: Up to 25%, once travel resumes
Reports to: Vice President, Clinical development
To apply: Send resume and cover letter to careers.us@gamida-cell.com.