Background: The Center for the Biomedical Advanced Research and Development Authority (BARDA) provides an integrated, systematic approach to the development of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies such as chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks; pandemic influenza (PI), and emerging infectious diseases (EID).Together with its industry partners, BARDA promotes the advanced development of medical countermeasures to protect Americans and respond to 21st century health security threats.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 (including viral and bacterial threats), Influenza and Emerging Infectious Diseases Division (IEIDD) as well as the research, development, manufacture, and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics and other medical devices/infrastructure vaccines and other preventives, and therapeutics.Candidates with experience in the following areas are desired: medicinal chemistry; preclinical development (animal models, pharmacology, toxicology); advanced clinical development (medical officers, immunologists, clinical operations); analytical product testing and testing development; quality control; clinical and/or regulatory policy; and/or manufacturing (chemistry, manufacturing, and controls); process development, process scale-up and process optimization; device development and manufacturing, reliability engineering, Software, Assay chemistry, microbiology, virology, immunology. Plastic consumable design and manufacturing. Experience in manufacturing scalability and capacity expansion and sterile/aseptic technic, sterile manufacturing/filling and sterile facilities (sterile gowning) Provide guidance and recommendations on key issues related to the area(s) identified above.Serve as advisor(s) on Technical Evaluation Panels (TEPs) to include white papers/market research abstracts, technical proposals, and budget proposals.Participate as subject matter experts on Program Coordination Teams (PCTs).Provide expert assessments, recommendations, and guidance as well as educational material to PCT and COR as needed.Provide subject matter expertise and advisory support to federal staff for development of cost estimates for notional programs/proposed work.Review and comment on study protocols, study reports, regulatory documents, presentations, proposals, and related documents.Develop work products (including but not limited to expert summary reports, expert opinion assessment reports, analysis reports, manuscript writing/contribution, and review and technical assessments on a wide variety of documents related to BARDA’s mission, including solicitations, white papers, proposals, and post-award contract documents and deliverables), as requested in their SME area and at their required level of expertise. Advise federal staff on the appropriateness and the 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 and concise summaries, including providing risk/benefit analyses and balanced recommendations. Participate and aid in strategic discussions, working with USG, in building new program areas in alignment with BARDA’s mission space. Provide recommendations for project development level portfolio management and oversight as required. Provide recommendations or advise on development, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts; Participate in Market Research efforts.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.Provide subject matter expertise in developing models to support U.S. FDA approval or licensure of MCMs for biological, chemical, and/or radiological/nuclear threats (e.g., Animal Rule pathway).Coordinate with program managers, scientists, and other subject matter experts as required.Provide subject matter expertise in conducting in vivo studies that demonstrate drug efficacy in animals expected to react with a response predictive of humans preferred to include the application of bioanalytical assays.Provide support to 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. Work with staff to draft and launch tenders to client’s animal model network to address those needs.Review and advise on non-clinical plans relating to animal models for safety, immunogenicity, and efficacy for BARDA’s partners’ candidate vaccines including attending joint client project team meetings.Serve as expert and advisor for review of applications for funding through calls for proposals for vaccine development and contribute to the due diligence process.Work with Project leaders for enabling science and/or preclinical leads for vaccine projects as needed.Serve as one of the experts in the evaluation of non-clinical data across the BARDA’s portfolio.
