BARDA Vaccine and Biologic Development Subject Matter Expert

Background. In 2006 the Biomedical Advanced Research and Development Authority (BARDA) was established to support and advance the development of vaccines, therapeutics, diagnostics, and innovative technologies for use during public health emergencies. The BARDA model’s success is codified in 1) 60+ Food and Drug Administration (FDA) approvals, licenses, and clearances, 2) 101 Biomedical products supported for COVID-19 response, and 3) 136 BARDA-supported COVID-19 partnerships. This success centers on BARDA’s public-private partnerships, which have accelerated the development of Medical Counter Measures (MCM) vital to our National Security. BARDA provides its partners critical capability and technical support needed to accelerate MCM regulatory approval and deployment, including support for advanced research and development (AR&D), FDA licensure, and clinical use.  Subject Matter Expert Responsibilities – General.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) as well as the research, development, manufacture and regulatory approval/ licensure/ clearance of medical countermeasures against these threats including but not limited to diagnostics, preventives, and therapeutics.Provide guidance and recommendations on key issues related to the area(s) identified above.Review study protocols, study reports, regulatory documents, presentations, proposals, and related documents.Provide senior-level briefing(s) to ASPR/BARDA as required.Prepare regular reports to ASPR/BARDA management on various technical issues identified as required.Provide recommendations for project development level portfolio management and oversight as required.Develop, implement, and consciously improve Total Life Cycle Cost (TLCC) efforts.Participate in Market Research efforts.Vaccine and Biologic Development Subject Matter Expert Specific Responsibilities.Serve as a subject matter expert in relevant field of experience(s) for vaccines related to the development and management of regulatory studies and licensure programs with current and planned BARDA vaccine development and acquisition contracts.Evaluate vaccine candidates for the feasibility of successful advanced development.Evaluate raw data generated from testing and data analyses.Review contract proposal and related documents and provide recommendations to USG.Provide senior-level briefing(s) to ASPR/BARDA as required; prepare regular reports to ASPR/BARDA management on various technical issues identified.Draft briefings that include technical alternatives between competing technologies for USG review.Provide support to BARDA’s Production Coordination Teams.Provide and summarize guidance documents and option papers on key issues related to the area(s) identified.Facilitate coordination across entities with the single goal of providing actionable information and knowledge to enable decision-making by leaders.Provide scientific/technology advice, technical oversight, and project management support in the areas of science and technology availability, technology maturity, and applicability of proposed candidate medical countermeasures through advanced development, DoD acquisition processes, production, and fielding.Collaborate with both internal and external partners, contributing to data.Engage in open and collaborative communication as a SME, at conferences (e.g., briefings, presentations, etc.) regarding science and technology innovations.Develop drafts and/or review and provide edits/comments to technical documentation (i.e., development/technology transfer reports, batch records, standard operating procedures, and regulatory submissions).Prepare and/or review draft protocols and study plans pertaining to a range of developmental efforts (i.e., manufacturing, non-clinical, clinical, and assay development) providing feedback in support of advanced development efforts.Develop drafts and assist the project team to coordinate responsibilities, oversee quality and regulatory management, and encourage timeliness of completion of protocols, IND applications, other regulatory submissions, and technical reports.Assist to identify and assess risks of new technologies and ongoing projects.