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

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