Senior Medical Director - California, United States - GQR

    GQR
    GQR California, United States

    1 month ago

    GQR background
    Description

    Our client is a Bay area cell therapy biotech developing therapeutics for autoimmune and inflammatory diseases.

    Reporting to the CMO, the Medical Director will 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. The right candidate will have significant experience in clinical development to join our team developing novel and innovative engineered T cell-based therapies for autoimmune diseases.

    Required experience and skills:

    • 5-10+ years of clinical research experience with 2-5+ years of industry experience in clinical development involved in the design and execution of clinical trials
    • MD (or ex-US equivalent) or MD-PhD degree required. Advanced degree or research experience in immunology preferred.
    • Specialty training in rheumatology and/or industry experience in clinical development of therapeutics in autoimmune diseases
    • Experience in early clinical development and translational medicine preferred.

    Primary responsibilities:

    • Development of clinical trial documents including protocols, ICFs, clinical development plans, and publications
    • Medical monitoring of clinical trials
    • Lead the development of clinical sections of regulatory documents including the IB, safety updates, clinical study reports, and responses to Health Authorities
    • Support transition of preclinical projects to clinical development

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