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    Clinical Development Lead - Pleasanton, United States - Dawar Consulting, Inc.

    Dawar Consulting, Inc.
    Dawar Consulting, Inc. Pleasanton, United States

    1 week ago

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    Description
    Our client, a world leader in Pharmaceuticals & In vitro diagnostics (IVD), is looking for a "Clinical Development Lead" for their Infection and Immunity department. The team is dedicated to providing clinical guidance and developing new laboratory and digital diagnostic products in the areas of infectious diseases and immunology. They are committed to addressing unmet medical needs and ensuring the products are safe, effective, and clinically useful.
    Job Type: Long-term Contract (Possibility Of Further Extension)
    Location: Pleasanton, CA (Hybrid and Remote work possible)

    Company Benefits include:
    • Healthcare (Medical, Dental, & Vision)
    • Paid Sick leave
    • 401k (with 2% employer match)

    Roles & Responsibilities:

    • Provide clinical guidance for the development of new laboratory and digital diagnostic products
    • Identify unmet medical needs and define clinical requirements for products
    • Lead clinical development and validation strategy for product registration
    • Assist with regulatory submissions and provide responses to regulatory agency questions
    • Work with cross-functional teams to design, implement, and publish clinical research studies
    • Present research findings and provide clinical expertise for risk and safety assessments.

    Education & Skills:

    • Graduate work in microbiology, virology, or immunology; MD and/or PhD preferred
    • 3+ years clinical experience in infectious diseases clinical care or medical microbiology/virology
    • 1+ years of clinical research experience, with knowledge of clinical trial design and statistical methods
    • Experience in laboratory techniques related to infectious diseases
    • Excellent organizational, communication, and project management skills
    • Ability to interface with key opinion leaders and clinical laboratorians
    • Laboratory work experience
    • Expertise in epidemiology, biostatistics, or public health
    • Some experience in diagnostics, medical devices, or pharmaceutical industry
    • Familiarity with regulatory processes and clinical software development
    • Expertise in relevant clinical areas such as immunocompromised host, sepsis, hepatitis, respiratory infections, or clinical immunology

    Interested? Please reply with your resume and contact details to .

    Best Regards,
    Dawar Consulting Inc.
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