Medical Director, Clinical Development
July 24
🏡 Remote – Anywhere in California
Description
• 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. • As the clinical trial study physician, be responsible for clinical deliverables and activities, including: • 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. • 5+ years of clinical research experience with 2+ years of industry experience in clinical development involved in the design and execution of clinical trials. Experience in early clinical development and translational medicine preferred. • Specialty training in rheumatology and/or industry experience in clinical development of therapeutics in autoimmune diseases. • 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.
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