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:
[email protected]<mailto:[email protected]>
Jian Wang, PhD, FCP
Associate Director for Regulatory Science
Office of Drug Evaluation IV, OND, CDER, FDA