BARDA Medical Diagnostics 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.Medical Diagnostics Subject Matter Expert Specific ResponsibilitiesExpert ability to deliver work products related to the evaluation and management of development, validation and manufacture of medical device systems, reagents, and devices.Provide strategic and technical direction to BARDA’s efforts to develop innovative treatments, diagnostic devices, and preventive measures that address threats posed by infectious diseases.Coordinate with program managers, scientists, and other subject matter experts as required.Serve as the reliable resource of technical counsel to BARDA and to companies that receive BARDA funding for medical diagnostics.Provide an interface between the government, operational staff, and BARDA’s industry partners.Demonstrate an extraordinary degree of ingenuity, creativity and resourcefulness in the development, application, evaluation and development of advanced technologies, scientific principles, theories, and concepts to ensure the appropriate development of medical countermeasures against infectious agents.Responsible for technical problem solving, data analyses, documentation of procedures and results, performing audits, and writing progress and final reports about medical countermeasures that address infectious diseases.Serve as scientific and technical representative to the Contracting Officer (CO) and Technical Project Officer (PO) concerning the evaluation and development of medical diagnostics against infectious diseases. Assess and monitor the risks associated with clinical development of medical diagnostics against infectious diseases.Review for technical correctness and give expert analysis regarding documents generated by BARDA contractors and federal employees.Actively participate in meetings with federal and contractor employees to obtain and evaluate project status and progress against contract milestones.  Perform site visits/audits with PO/CO (or designated representative) to contractor facilities, and/or facilities of subcontractors, to verify compliance with contract requirements.Use extensive technical and industry knowledge to provide insight and technical counsel concerning BARDA’s strategic position within the community developing infectious disease medical countermeasures.Independently perform activities consistent with established organizational practices, precedents, policies, and strategic objectives set forth by BARDA management. Perform analytical, interpretive, evaluative and/or constructive thinking. Where appropriate or required, develop new methods and processes.