Senior Clinical Studies Physician | Healthcare and Life Sciences [HHS114019]
Core
Senior Clinical Studies Physician providing subject matter expertise and advisory support for the development of medical countermeasures against chemical, biological, radiological, and nuclear threats, as well as emerging infectious diseases.
Role type
Senior Clinical Studies Physician (Subject Matter Expert)
Builds
Medical countermeasures including diagnostics, vaccines, therapeutics, and antimicrobials for BARDA
Domain
Healthcare and Life Sciences / Biopharmaceuticals / Public Health Security
Required skills
Managing complex clinical studies, overseeing CROs in compliance with GCP/GLP, expertise in therapeutic areas (infectious diseases, burns, radiation injury, pulmonary medicine, pediatrics, hematology/oncology), regulatory compliance, strategic program management
Preferred skills
Experience with BARDA programs, knowledge of medicinal chemistry, preclinical development, sterile manufacturing, process scale-up, Total Life Cycle Cost management
Technologies
GCP, GLP, CRO management platforms
Responsibilities
Serve as subject matter expert on Technical Evaluation Panels and Program Coordination Teams, review and comment on study protocols and regulatory documents, develop expert summary reports and technical assessments, advise federal staff on program success probability and cost estimates, provide recommendations for portfolio management and Total Life Cycle Cost efforts
Seniority
Senior, strategic leadership
