Senior Decentralized Clinical Care SME | Healthcare and Life Sciences [HHS115020]
Core
Senior Subject Matter Expert providing advisory support and strategic guidance on decentralized clinical trials (DCTs) and medical countermeasures for BARDA/HHS.
Role type
Senior IC Clinical Research SME (Decentralized Trials)
Builds
Expert assessments, recommendations, white papers, and strategic guidance for federal program development.
Domain
Healthcare and Life Sciences / Public Health / Biodefense
Deliverable
dashboards & analysis
Required skills
Decentralized clinical trial design and execution, Real-World Evidence (RWE) studies, Medical countermeasure development, Regulatory policy, Clinical operations, Quality control, Process scale-up, Sterile manufacturing, Non-traditional site management (telemedicine, retail pharmacies), CRO landscape knowledge, Data management systems, Laboratory facilities oversight
Preferred skills
Medicinal chemistry, Preclinical development, Immunology, Virology, Microbiology, Device development, Total Life Cycle Cost (TLCC) management, Market research
Technologies
Telemedicine platforms, Data management systems, Laboratory information systems
Responsibilities
Serve as advisor on Technical Evaluation Panels and Program Coordination Teams, Review and comment on study protocols and regulatory documents, Provide expert opinion on DCT proposals and capabilities, Inform on the landscape of organizations conducting DCTs, Advise on the appropriateness and probability of success for proposed statements of work, Participate in strategic discussions to build new program areas, Provide recommendations for portfolio management and oversight.
Seniority
Senior, hands-on IC
