Senior Nonclinical Models SME | Healthcare and Life Sciences [HHS118023]
Core
Senior Subject Matter Expert providing nonclinical development expertise for medical countermeasures against CBRN threats and emerging infectious diseases.
Role type
Senior IC nonclinical models SME (biopharmaceuticals)
Builds
Medical countermeasures (diagnostics, vaccines, therapeutics) for BARDA
Domain
Healthcare and Life Sciences / Biotechnology / Public Health
Required skills
nonclinical program management, animal model development, in vivo study design, bioanalytical assays, regulatory pathway knowledge (FDA/Animal Rule), CBRN research expertise, CRO oversight, total life cycle cost analysis
Preferred skills
medicinal chemistry, toxicology, pharmacology, sterile manufacturing, process scale-up, immunology, virology, microbiology
Technologies
bioanalytical assays, sterile facilities, CRO networks
Responsibilities
Guide and monitor sponsored research with Contract Research Organizations (CROs); Provide subject matter expertise in developing animal models to support FDA approval; Conduct in vivo studies demonstrating drug efficacy; Review study protocols and regulatory documents; Advise federal staff on program success probability and cost estimates; Participate in Technical Evaluation Panels and Program Coordination Teams
Seniority
Senior, hands-on IC