Clinical Operations SME | Healthcare and Life Sciences [HHS104009]
Core
Provide subject matter expertise and advisory support for clinical operations in medical countermeasures R&D for BARDA, covering chemical, biological, radiological, and nuclear threats.
Role type
Senior Clinical Operations SME (Healthcare and Life Sciences)
Builds
Medical countermeasures (diagnostics, vaccines, therapeutics) and regulatory approval pathways
Domain
Healthcare and Life Sciences / Biopharmaceuticals / Government Contracting
Required skills
Clinical trial operations (Phase I-IV), Regulatory submission processes, Project management, Risk assessment, Budget and timeline management, CRO proposal evaluation
Preferred skills
Medicinal chemistry, Preclinical development, Manufacturing scalability, Sterile manufacturing, FDA guidelines familiarity
Technologies
None explicitly listed
Responsibilities
Support BARDA Program Offices as an SME in threat areas and medical countermeasures development; Serve as advisor on Technical Evaluation Panels; Review study protocols and regulatory documents; Develop expert reports and cost estimates; Advise on contractor statements of work
Seniority
Senior, hands-on IC with executive responsibilities
