Senior Clinical Operations SME | Healthcare and Life Sciences [HHS113018]
Core
Senior Clinical Operations SME supporting BARDA's R&D of medical countermeasures for CBRN events, pandemics, and emerging infectious diseases.
Role type
Senior IC clinical operations subject matter expert
Builds
Medical countermeasures (diagnostics, vaccines, therapeutics, devices) and regulatory approval pathways
Domain
Healthcare and Life Sciences / Biopharmaceuticals / Government Contracting
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial operations (Phase I-IV), Registrational Phase II/III trial management, FDA regulatory submission processes, CRO proposal evaluation, RTOR development, Risk assessment and mitigation, Project management, Budget and timeline management, Study protocol review, Regulatory document review
Preferred skills
Medicinal chemistry, Preclinical development, Advanced clinical development, Manufacturing scalability, Sterile manufacturing, Device development, Immunology, Virology, Microbiology, Plastic consumable design
Technologies
None explicitly stated
Responsibilities
Support BARDA Program Offices as SME in Chemical, Radiological/Nuclear, Burn/Blast, Biological, and Influenza/IEIDD fields; Serve on Technical Evaluation Panels (TEPs) and Program Coordination Teams (PCTs); Review study protocols, regulatory documents, and proposals; Develop expert reports, cost estimates, and technical assessments; Advise federal staff on Statement of Work appropriateness and success probability; Manage project timelines, budgets, and regulatory compliance.
Seniority
Senior, hands-on IC with executive-level responsibilities