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ORISE Fellowship Opportunities at FDA/Office of New Drug

From: Wang, Hechuan * <Hechuan.Wang>
Date: Mon, 17 Jul 2017 17:55:10 +0000

The Office of Drug Evaluation IV in the Office of New Drugs at FDA is seeki=
ng 2-3 Fellows who are interested in working on regulatory science projects=
 focused on 1) neonatal and pediatric pharmacometrics; 2) Evaluating Bayes=
ian Methods for Pediatric Extrapolation; 3) Physiologically based pharmacok=
inetic (PBPK) modeling to predict drug disposition during pregnancy and lac=
tation . We are interested in using PKPD and PBPK approaches to address que=
stions in neonates and pediatrics clinical trials during drug development.
Opportunities are available for current students in a Ph.D. or other profes=
sional doctorate program and graduates with a doctoral degree in pediatrics=
, clinical pharmacology, pharmacometrics, PKPD, PBPK or statistics. Hands-o=
n 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 ex=
pected for candidates.

Interested applicants should submit Curriculum Vitae to:
Jian Wang, PhD, FCP
Associate Director for Regulatory Science
Office of Drug Evaluation IV, OND, CDER, FDA

Received on Mon Jul 17 2017 - 13:55:10 EDT

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