BARDA Senior Decentralized Clinical Care SME

BackgroundIn 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.  Job ResponsibilitiesSupport BARDA program managers as advisor on decentralized clinical trials (DCTs).Participate in BARDA program teams to support evaluation of BARDA products that are being evaluated in decentralized clinical settings or with decentralized capabilities and tools.Review and provide expert opinion and recommendation on proposals that include decentralized clinical trial capabilities and provide feedback to Government program Managers.Serve as a subject matter expert (SME) in the design, execution and management of decentralized clinical trials research and clinical care delivery in non-traditional site-based healthcare settings for BARDA funded effortsInform on landscape of organizations conducting DCTs and provide insight as to both challenges and strategic value of DCTs.