Subject Matter Expert - Washington - Direct Staffing Inc

    Direct Staffing Inc
    Direct Staffing Inc Washington

    1 day ago

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    Description

    Subject Matter Expert for Infectious Diseases

    • Full-time
    • Pharmaceutical/Biotech
    • 10-15 years of experience
    • Relocation possible
    • Bonus eligible

    Job Description: As a Subject Matter Expert (SME) for the Development and Evaluation of Infectious Disease Countermeasures and Diagnostic Devices, you will provide strategic and technical direction to BARDA's efforts.

    Position Overview: The Biomedical Advanced Research and Development Authority (BARDA) is responsible for developing medical countermeasures against infectious agents. You will serve as a reliable resource of technical counsel to BARDA and its industry partners.

    Main Responsibilities:

    1. Serve as scientific and technical representative to Contracting Officer and Technical Project Officer concerning medical countermeasures against infectious diseases.
    2. Assess and monitor risks associated with clinical development of medical countermeasures against infectious diseases.
    3. Provide technical opinions to the Contracting Officer and Technical Project Officer.
    4. Develop concept ideas for preparedness and response acquisitions.
    5. Evaluate documents generated by BARDA contractors and federal employees for technical correctness.
    6. Participate in meetings with federal and contractor employees to obtain project status and progress.
    7. Perform site visits/audits to verify compliance with contract requirements.
    8. Inform Contracting Officer and Technical Project Officer of any increase/decrease in risk to project success.
    9. Assist in contract negotiations on technical matters.
    10. Use technical knowledge to provide insight and technical counsel concerning BARDA's strategic position.
    11. Independently perform activities consistent with organizational practices and policies.
    12. Maintain critical human relations skills to create teaming partnerships.

    Requirements:

    • A board-certified medical doctor with specialty in internal medicine or pediatrics and subspecialty training in infectious disease focused on virology.
    • At least 15 years of experience in drug/device/procedure development in infectious disease with emphasis on late-stage development.
    • An established reputation as a subject matter expert evidenced by peer-reviewed publications and professional associations.
    • Excellent written and verbal communication skills.

    Desired Qualifications:

    • Expertise in development of pharmaceutical, biological, or diagnostic products with particular expertise in clinical development.
    • Successful development of a product for infectious disease through FDA approval and licensure.
    • Experience identifying and resolving developmental technical problems.
    • Extensive clinical experience in treatment of drug-resistant infections.
    • Strong people skills with team-oriented leadership approach.


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