Job description
Senior or Executive Medical Director - Clinical Development
Emeryville, CA
Our client is a cell therapy company developing innovative medicines for inflammatory and autoimmune diseases. GQR is seeking a highly motivated Senior Medical Director or Executive Medical Director, with significant experience in clinical development, to join this team.
Responsibilities:
- Reporting to the Chief Medical Officer
- Serves 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.
- MD (or ex-US equivalent) or MD-PhD degree required. Advanced degree or research experience in immunology preferred.
- 6-10+ years of clinical research experience with 5+ 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.