Medical Director/Senior Medical Director - San Francisco, United States - GQR

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    Description

    The Director/Senior Medical Director, reporting to the Chief Medical Officer, plays a pivotal role in steering clinical development initiatives. With a focus on ensuring adherence to GCP, SOPs, and regulatory standards, this role orchestrates the planning and execution of clinical studies, driving programs through the research process efficiently.

    Key Responsibilities:

    • Design, oversee, and execute clinical deliverables to support defined program objectives, including document development, contribution to key documents, and providing medical and scientific input throughout study lifecycle.
    • Review, analyze, interpret, and present clinical data internally and externally, representing clinical studies or programs on relevant teams or subteams.
    • Develop and optimize KOL and investigator communication strategies, organizing advisory board and investigator meetings as needed.

    Qualifications, Education & Experience:

    • MD or non-US equivalent.
    • 10+ years of clinical trial experience encompassing early and late-phase development, with at least 4 years in the industry. Consideration may be given to candidates with exceptional experience in other therapeutic areas, particularly if they demonstrate potential for application in oncology.
    • Expertise in radiopharmaceuticals is a plus.
    • Profound understanding of clinical development phases, including familiarity with drug approval processes in the US and internationally.
    • Experience in all aspects of protocol conduct, from writing to execution, analysis, and reporting.
    • Strong knowledge of FDA regulations, Good Clinical Practices, and clinical trials guidelines.

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