Medical Director/Sr. Medical Director, Clinical Development

Responsibilities

• Serve as the physician lead for CAR T-cell therapy clinical trials in autoimmune disease indications, in partnership with internal and external cross-functional teams.
• Oversee medical monitoring of clinical trials, including engagement with site investigators and external medical monitors.
• Partner with clinical operations, biometrics, regulatory, and commercial teams to ensure alignment on strategy and execution.
• Lead design, execution, and interpretation of clinical trials across assigned program
• Provide medical and scientific input into clinical development plans, study protocols, investigator brochures, and regulatory submissions.
• Medical review, analysis, and interpretation of safety, efficacy, and PK and biomarker data.
• Development of clinical trial documents including protocols, ICFs, clinical development plans, and publications.
• Lead the development of clinical sections of regulatory documents including the IB, safety updates, clinical study reports, and responses to Health Authorities.
• Actively engage with external investigators and researchers to identify, evaluate, and support investigator sponsored studies and drive research collaborations.

Qualifications

• MD, DO, (or ex-US equivalent) or MD-PhD degree required.
• 5+ years of clinical research experience with 3+ years of industry experience in late phase clinical development involved in the design and execution of clinical trials. Experience in late-stage clinical development preferred.
• Specialty training in neurology, rheumatology, nephrology and/or industry experience in clinical development of cell therapies and/or therapies for autoimmune diseases is highly preferred.
• Proven ability to interpret, discuss and present efficacy and safety data.
• Strong knowledge of GCP/ICH, clinical trial design, clinical development processes, and regulatory requirements.
• Strong ability to communicate and establish effective working relationship with investigators, collaborators, scientific advisors, CROs, and corporate partners.