Full-Time BARDA Clinical Sciences SME Burns & Trauma

Background: The Center for the Biomedical Advanced Research and Development Authority (BARDA) provides an integrated, systematic approach to the development of necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.General SME Responsibilities:Support BARDA Program Office(s) as a subject matter expert in the fields of Chemical Threats, Radiological/Nuclear Threats, Burn and Blast Injuries, or Biological Threats, Influenza and Emerging Infectious Diseases Division. Candidates with experience in medicinal chemistry, preclinical development, advanced clinical development, analytical product testing, quality control, clinical and/or regulatory policy, manufacturing, process development, device development, reliability engineering, Assay chemistry, microbiology, virology, immunology, plastic consumable design, manufacturing scalability, sterile/aseptic technic, sterile manufacturing, sterile facilities are desired. Provide guidance and recommendations on key issues related to these areas. Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers, technical proposals, and budget proposals. Participate as subject matter experts on Program Coordination Teams (PCTs). Provide expert assessments, recommendations, and guidance to PCT and COR as needed. Provide subject matter expertise to federal staff for development of cost estimates. Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents. Develop work products (expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution). Advise federal staff on the appropriateness and probability of success of Contractor proposed statements of work. Make suggestions on ways to improve those statements of work. Experience distilling complex information into informative summaries, including providing risk/benefit analyses and balanced recommendations. Participate in strategic discussions with USG. Provide recommendations for project development level portfolio management and oversight. Provide recommendations or advise on development, implement, and improve Total Life Cycle Cost (TLCC) efforts. Participate in Market Research efforts.Education and Experience: A doctoral degree (MD/DO) in relevant fields with at least 15 years of clinical practice, surgical and preferably pharmaceutical industrial experience, and extensive training in the relevant field. SME in clinical sciences and medical product development.Benefits: Competitive salary, comprehensive health plan, dental and vision coverage, company-paid life & disability insurance policies, 401(k) plan with company match, educational reimbursement program.Employment Type: Full-time.

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