Full-Time BARDA Senior Clinical Studies Physician

Clinical Studies Physician SME will provide clinical development subject matter expertise support to BARDA's MCM Programs.

Deliverables include work products related to the management of clinical studies and programs within BARDA vaccine, therapeutic, and/or antimicrobial advanced development and acquisition contracts.

Responsibilities:

• Oversee CROs to conduct clinical trials in accordance with clinical development plans, GCP, GLP, and regulatory requirements.
• Maintain in-depth expertise in relevant therapeutic areas (infectious diseases, burns, radiation injury, etc.).
• Support BARDA Program Office(s) as a subject matter expert in various threat areas (chemical, radiological, biological).
• Provide guidance and recommendations on key issues related to medical countermeasures.
• Serve as advisor on Technical Evaluation Panels (TEPs).
• Participate in Program Coordination Teams (PCTs).
• Provide expert assessments, recommendations, and guidance to PCTs and CORs.
• Provide subject matter expertise to federal staff for cost estimates.
• Review and comment on study protocols, reports, regulatory documents, proposals, and presentations.
• Develop work products (expert reports, analysis reports, etc.).
• Advise federal staff on contractor proposals.
• Distill complex information into informative summaries, including risk/benefit analyses.
• Participate in strategic discussions and program area development.
• Provide recommendations for project development.
• Provide recommendations on Total Life Cycle Cost (TLCC) efforts.
• Participate in Market Research.

Experience Required:

• At least 15 years of relevant industry experience beyond doctoral degree.
• Advanced degree in medicine or pharmacy.
• Experience in development of medical countermeasures.
• Current, active, full, and unrestricted physician license.

Benefits:

• Competitive salary
• Comprehensive health plan (dental/vision)
• Company-paid life & disability insurance
• 401(k) plan with company match
• Educational reimbursement program

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