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  • BARDA Nonclinical Models Subject Matter Expert - Washington - BryceTech

    BryceTech
    BryceTech Washington

    1 week ago

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    Description

    Job Description

    The Center for the Biomedical Advanced Research and Development Authority (BARDA) is seeking a highly qualified subject matter expert to provide guidance and support on various aspects of medical countermeasure development.

    As a Subject Matter Expert (SME), you will be responsible for providing expertise in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats, including viral and bacterial threats, influenza, and emerging infectious diseases.

    You will serve as an advisor on Technical Evaluation Panels (TEPs) and participate as a subject matter expert on Program Coordination Teams (PCTs). Your duties will include reviewing and commenting on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.

    Additional responsibilities include developing work products, such as expert summary reports and analysis reports, and advising federal staff on the appropriateness and probability of success of contractor-proposed statements of work. You will also participate in strategic discussions and provide recommendations for project development level portfolio management and oversight.

    Nonclinical Model SME Specific Responsibilities

    • Apply expert ability to deliver work products related to the development and management of programs within current and planned BARDA nonclinical contracts and task orders.
    • Provide nonclinical development subject matter expertise support throughout various programs within BARDA for MCM development.
    • Develop models to support U.S. FDA approval or licensure of MCMs for biological, chemical, and/or radiological/nuclear threats.
    • Coordinate with program managers, scientists, and other subject matter experts as required.
    • Conduct in vivo studies that demonstrate drug efficacy in animals expected to react with a response predictive of humans.
    • Support BARDA's nonclinical development networks guiding and monitoring sponsored research with Contract Research Organizations (CROs).
    • Analyze the need for improved or standardized animal models for BARDA's priority pathogens.
    • Review and advise on non-clinical plans relating to animal models for safety, immunogenicity, and efficacy for BARDA's partners' candidate vaccines.
    • Serve as expert and advisor for review of applications for funding through calls for proposals for vaccine development.
    • Work with Project leaders for enabling science and/or preclinical leads for vaccine projects.
    • Serve as one of the experts in the evaluation of non-clinical data across the BARDA's portfolio.

    Qualifications

    • Doctoral degree(s) in biology or similar field(s) with commensurate experience(s) in nonclinical development addressing bacterial and viral biothreat indications and toxins.
    • At least ten (10) years of relevant industry or commensurate professional experience.
    • Experience in non-clinical study design, study execution, data interpretation, and reporting with an understanding of all types of non-clinical studies and how this data fits into overall vaccine development, regulatory submissions, and licensure.
    • Strong expertise in animal models, animal ethics policies, experience with US FDA Animal Rule, non-clinical immunology, correlates of protection, mode of action, and safety.
    • Experience working in high-containment (BSL3/4) laboratories or facilities is desirable but not mandatory.
    • Established reputation as a subject matter expert as evidenced by peer-reviewed publications and membership in professional associations is preferred.

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