Full-Time BARDA Clinical Sciences SME

Background: The Center for the Biomedical Advanced Research and Development Authority (BARDA) provides an integrated approach to developing vaccines, drugs, therapies, and diagnostics for public health emergencies (e.g., CBRN, pandemic influenza, emerging infectious diseases). BARDA works with industry partners to develop medical countermeasures.

Job Summary: The Clinical Sciences and Medical Product Development SME for Burns & Trauma Care will provide expertise in burn wound care, imaging, tissue engineering, preclinical models for testing therapeutic products (burn and wound healing, inhalation injuries, blast trauma).

Responsibilities:

• Support BARDA Program Office(s) as a SME in various threat areas (chemical, radiological/nuclear, burn/blast, biological, influenza, EIDs).
• Support research, development, manufacturing, and regulatory aspects of medical countermeasures (diagnostics, devices, vaccines, therapeutics).
• Provide guidance and recommendations on key issues related to the above areas.
• Serve on Technical Evaluation Panels (TEPs), reviewing white papers, proposals, and budgets.
• Participate in Program Coordination Teams (PCTs).
• Provide expert assessments, recommendations, and educational materials to PCTs and CORs.
• Develop cost estimates for proposed programs.
• Review and comment on study protocols, reports, regulatory documents, proposals, presentations.
• Develop work products (expert reports, analyses, manuscripts).
• Advise federal staff on contractor proposals and improvement suggestions.
• Distill complex information into concise summaries, including risk/benefit analyses and recommendations.
• Participate in strategic discussions to develop new program areas.
• Provide recommendations for portfolio management.
• Provide recommendations on Total Life Cycle Cost (TLCC) efforts and market research.
• Provide subject matter expertise in burn wound care, imaging, tissue engineering/regenerative medicine, and preclinical models.

Qualifications:

• Doctoral degree (MD/DO) in relevant fields (clinical sciences, biochemistry, life/biomedical sciences, biomedical engineering)
• 15+ years of clinical practice, surgical and/or pharmaceutical industrial experience
• Extensive training in the relevant field
• SME in clinical sciences and medical product development, with preference for products related to chronic wounds, burns, trauma, internal medicine (imaging, biologics, drugs, combination products).

Compensation & Benefits: Competitive salary, comprehensive health plan (dental/vision), life/disability insurance, 401(k) plan with match, educational reimbursement.

Work Type: 100% remote.

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