Full-Time BARDA Senior Medical Diagnostics SME

Background: The Center for Biomedical Advanced Research and Development Authority (BARDA) develops vaccines, drugs, therapies, and diagnostic tools for public health emergencies (CBRN, PI, EID). BARDA partners with industry to develop medical countermeasures.

Job Responsibilities:

• Supervise less experienced medical diagnostics SMEs.
• Serve as primary interface with BARDA and industry senior leadership on medical diagnostics.
• Provide strategic and technical direction for BARDA's development of innovative treatments, diagnostic devices, and preventive measures for infectious diseases.
• Serve as a technical resource for BARDA and funded companies.
• Coordinate with program managers, scientists, and other SMEs.
• Provide interface between government, operational staff, and BARDA industry partners.
• Develop, apply, evaluate, and advance technologies, scientific principles, theories, and concepts to develop medical countermeasures.
• Solve technical problems, analyze data, document procedures and results, conduct audits, and write reports on medical countermeasures.
• Serve as scientific and technical representative to Contracting and Project Officers.
• Assess and monitor risks in clinical development of medical diagnostics.
• Review documents generated by BARDA contractors and federal employees for technical correctness.
• Attend meetings to evaluate project status and progress.
• Conduct site visits/audits to contractor and subcontractor facilities to verify compliance.
• Inform PO/CO of risk changes and generate contingency plans.
• Assist in contract negotiations on technical matters.
• Provide insight and technical counsel on BARDA's strategic position.
• Independently perform activities consistent with BARDA policies and objectives.
• Perform analytical, interpretive, evaluative and/or constructive thinking.
• Develop new methods and processes as needed.
• Develop and lead teams, build partnerships, and educate others.
• Serve as advisor on Technical Evaluation Panels (TEPs).
• Participate as SME on Program Coordination Teams (PCTs).
• Provide subject matter expertise for cost estimates of notional programs/proposed work.
• Review study protocols, study reports, regulatory documents, presentations, proposals, etc.
• Develop work products (e.g., reports, analysis, assessments) for BARDA's mission.
• Advise federal staff on contractor proposed statements of work, offering suggestions for improvement.
• Conduct risk/benefit analyses and provide balanced recommendations.
• Participate in strategic discussions on new program areas aligned with BARDA's mission.
• Provide recommendations for project portfolio management and oversight.
• Provide recommendations or advise on development, implementation, and improvement of Total Life Cycle Cost (TLCC) efforts.
• Participate in market research efforts.

Experience and Qualifications:

• 15+ years of relevant industry experience
• PhD in life sciences (immunology, molecular biology, biochemistry, microbiology) or Master's/Bachelor's with commensurate industry experience in physical sciences (engineering, physics, computer science).
• Commercial experience developing/manufacturing molecular or immunologic diagnostic components/systems.

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

Work Location: 100% Remote.

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