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  • Senior Medical Director - Crawley, England, United Kingdom - JR United Kingdom

    JR United Kingdom
    JR United Kingdom Crawley, England, United Kingdom

    1 week ago

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    Description

    Job Title: Senior Medical Director

    We are seeking a highly experienced Senior Medical Director to join our Clinical Development team in Crawley, West Sussex.

    About the Role:

    The successful candidate will serve as the Clinical Lead for one or more oncology clinical trials, working closely with our US-based team and EU sites. The role will involve leading cross-functional teams, designing and executing clinical trials, and ensuring patient safety.

    Main Responsibilities:

    • Medical Monitoring: Serve as the medical monitor for assigned studies, including design, execution, and interpretation of study data.
    • Patient Safety: Ensure patient safety on clinical trials and adherence to Good Clinical Practices (GCP).
    • Cross-Functional Collaboration: Act as liaison between Clinical Development and other internal groups for assigned studies, including working closely with clinical operations, pharmacovigilance, manufacturing, quality, and biomarker groups.
    • Scientific Input: Provide scientific and clinical input to study-related documents and analysis plans, including informed consent forms, clinical research forms, statistical analysis plans, and clinical pharmacology and biomarker analysis plans.
    • Regulatory Documents: Contribute to the development of regulatory documents in support of regulatory submissions, including the clinical section of INDs and CTAs, safety reports, responses to regulatory authorities, and Ethics Committees/IRBs.

    Requirements:

    • MD or equivalent ex-US medical degree with 4-6 years of experience in Oncology.
    • 2-4 years of clinical trial experience, with experience in phase 1 trials an advantage.
    • Pharmaceutical/Biotech industry experience in clinical development and medical monitoring.
    • Strong oral and written communication skills.
    • Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate.

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