The Office of Drug Evaluation IV in the Office of New Drugs at FDA is seeking 2-3 Fellows who are interested in working on regulatory science projects focused on 1) neonatal and pediatric pharmacometrics; 2) Evaluating Bayesian Methods for Pediatric Extrapolation; 3) Physiologically based pharmacokinetic (PBPK) modeling to predict drug disposition during pregnancy and lactation . We are interested in using PKPD and PBPK approaches to address questions in neonates and pediatrics clinical trials during drug development. Opportunities are available for current students in a Ph.D. or other professional doctorate program and graduates with a doctoral degree in pediatrics, clinical pharmacology, pharmacometrics, PKPD, PBPK or statistics. Hands-on experience with modeling and simulation software (e.g. NONMEM, SAS, Splus/R, Trial Simulator, WinBUGs, Phoenix, Monolix, GastroPlus, PKSIM, SimCYP, etc.) and good knowledge of PK/PD modeling principles and statistics are expected for candidates.
Interested applicants should submit Curriculum Vitae to: jian.w...@fda.hhs.gov<mailto:jian.w...@fda.hhs.gov> Jian Wang, PhD, FCP Associate Director for Regulatory Science Office of Drug Evaluation IV, OND, CDER, FDA