Medical Director, Clinical Development

Responsibilities:

• Serve as the medical lead for CAR T-cell therapy clinical trials in multiple autoimmune disease indications, in partnership with internal and external cross-functional teams.
• Support, as the clinical representative, the transition of preclinical projects to clinical development.
• Medical monitoring of clinical trials.
• 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.

Requirements:

• MD (or ex-US equivalent) or MD-PhD degree required. Advanced degree or research experience in immunology preferred.
• 3+ years of clinical research experience with 2+ years of industry experience in late phase clinical development involved in the design and execution of clinical trials. Experience in late clinical development preferred.
• Specialty training in neurology, rheumatology, nephrology and/or industry experience in clinical development of therapeutics in autoimmune diseases is highly preferred.
• Proven ability to interpret, discuss and present efficacy and safety data.
• Working 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.

Originally posted on Himalayas