- 5-10+ years of clinical research involvement with 2-5+ years in the industry specifically focusing on clinical trial design and implementation
- Must hold an MD (or equivalent) or MD-PhD degree. Additional qualifications or research background in immunology would be advantageous.
- Specialized training in rheumatology and/or industry experience in developing therapeutics for autoimmune disorders
- Preferably experienced in early clinical development and translational medicine
- Creation of various clinical trial documents such as protocols, informed consent forms (ICFs), development plans, and scientific publications
- Medical oversight of clinical trials
- Leading the drafting of clinical sections in regulatory submissions including Investigator's Brochures (IB), safety updates, study reports, and responses to Regulatory Authorities
- Assisting in the transition of preclinical projects into clinical development
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Senior Medical Director - California, United States - GQR
Description
Our client operates in the field of cell therapy biotechnology in the Bay area, focusing on creating treatments for autoimmune and inflammatory conditions.
Reporting directly to the Chief Medical Officer (CMO), the Medical Director will take on the role of leading medical activities for CAR T-cell therapy trials targeting various autoimmune diseases. This will involve close collaboration with internal and external teams. The ideal candidate should possess extensive experience in clinical development, particularly in the realm of innovative T cell-based therapies for autoimmune conditions. This opportunity allows for remote work with occasional travel.
Key qualifications:
Main responsibilities:
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