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    Medical Director - Cambridge, United States - Knewin

    Knewin
    Knewin Cambridge, United States

    4 weeks ago

    Default job background
    Description

    Seeking an experienced Director, Clinical Development to join our team and embark on a unique journey of advancing our clinical development programs in rare cholestatic liver disease. In this position, you will be an integral part of the clinical development team, supporting the execution of late-stage clinical studies. The ideal candidate will have outstanding communication skills, attention to detail, and the ability to thrive independently in a highly innovative and fast-paced environment. Provide medical expertise and leadership in designing and implementing clinical development strategies aligned with company objectives.

    Job Responsibilities

    Clinical Trial Strategy and Design:

    Collaborate with cross-functional teams (including Clinical Operations, Biostatistics Regulatory Affairs, Patient Safety, and Pharmacology/Pharmacometrics) to design and implement clinical trials

    Ensure that clinical trial protocols align with scientific and regulatory requirements

    Oversee patient recruitment, data collection, and safety monitoring during trials

    Medical Oversight:

    Provide medical expertise to study teams, investigators, and site staff

    Review and interpret clinical trial data, including safety and efficacy endpoints

    Make informed decisions based on medical insights to optimize trial outcomes

    Regulatory Interactions:

    Engage with regulatory agencies (such as the FDA or EMA) during clinical development

    Prepare and submit clinical trial applications, investigator brochures, and other regulatory documents

    Address regulatory queries and ensure compliance with guidelines

    Clinical Development Strategy:

    Contribute to the overall clinical development strategy for the companys pipeline products

    Identify opportunities for expansion into new indications or patient populations

    Evaluate scientific literature and competitive landscape to inform strategic decisions

    KOL Engagement and Scientific Communication:

    Build relationships with Key Opinion Leaders (KOLs) in relevant therapeutic areas

    Present clinical trial results at scientific conferences and meetings

    Collaborate with external experts to enhance product understanding

    Team Leadership and Mentorship:

    Depending on the candidate's expertise level, the responsibilities may include leading a team of clinical professionals, including Clinical Scientists and Medical Monitors

    Effectively fosters productive and collegial working relationships with internal and external stakeholders in a cross-functional, matrix environment

    Additional Info

    This is a hybrid/remote role for the candidate; however, if the candidate is local to the area, the candidate will be expected to come into the office occasionally

    Advanced scientific degree (MD or DO, PhD, PharmD)

    Must have experience leading all aspects of clinical trials

    Must have pharma clinical trial /R&D experience (3-5 years)

    Rare disease experience and or gastroenterology/hepatology experience in clinical development preferred

    Solution- and results-oriented, with a sense of urgency

    Must have experience and be willing to perform in-depth clinical data review

    #J-18808-Ljbffr

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