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    Senior Director of Clinical Development Medical Affairs - Bridgewater, United States - Green Key Resources

    Green Key Resources
    Green Key Resources Bridgewater, United States

    1 week ago

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    Description

    Summary:

    The Senior Director of Clinical Development Medical Affairs (CDMA) is tasked with spearheading the strategy and oversight for the hepatology drug program, ensuring alignment with brand objectives, incorporation of relevant insights, and the generation of a robust R&D plan catering to unmet patient needs.

    This individual also leads a multi-disciplinary team through the Stage Gate process effectively.


    Responsibilities:
    Develops and aligns hepatology program strategy with R&D Leadership and Brand Team.
    Leads risk mitigation and contingency planning, escalating risks as necessary.
    Provides scientific and medical expertise for clinical research activities related to registration.
    Identifies key opinion leaders/principal investigators to validate program assumptions.
    Offers medical interpretation of efficacy and safety data and participates in interactions with regulatory authorities.
    Contributes to project publication plan and collaborates with commercial teams on launch activities.
    Maintains relationships with external experts and represents the company with outside groups.
    Contributes to regulatory discussions and participates in various internal committees.
    Manages budgets for CDMA activities.


    Requirements:


    Advanced degree (PhD, PharmD, MD) with specialization in hepatology/nephrology/critical care.10+ years' pharmaceutical experience in Program Management, Clinical Development, and/or Medical Affairs.

    Experience in clinical study design and execution, working effectively in multidisciplinary teams.
    Familiarity with global regulatory agencies and demonstrated business acumen.
    Excellent communication, interpersonal, and leadership skills with a focus on compliance.
    Experience with medical device/drug device combination products.
    Proven track record of leading clinical development programs to regulatory approvalDate Posted
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