Director/Senior Director, Clinical Development

Gamida Cell is an advanced cell therapy company committed to finding cures for cancer and other serious diseases. We apply a proprietary expansion platform to allogeneic cell sources, including umbilical cord blood-derived cells and NK cells, which leverages the properties of nicotinamide (NAM) to create products with the potential to redefine standards of care.

Omidubicel, Gamida Cell’s lead investigational product candidate, is under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies, and has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. Omidubicel met all of its primary and secondary endpoints in a Phase 3 study. Gamida Cell plans to submit a BLA for omidubicel by the end of 2021 with an anticipated product approval and launch in mid-2022. Gamida Cell is also pioneering modified and unmodified NAM-enabled NK cell therapies targeted at solid tumor and hematological malignancies.

Gamida Cell is a global, publicly traded biotechnology company (Nasdaq: GMDA) with locations in Israel and the United States. Additional information can be found on our website at www.gamida-cell.com.

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.