Research Project Description

PBPK Modeling Postdoctoral Fellowship
Office of Translation Sciences
Office of Clinical Pharmacology
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Silver Spring, MD

FDA-CDER-2013-0008

Project Description:

A postdoctoral fellowship is available within the Office of Translation Sciences (OTS) of the Office of Clinical Pharmacology (OCP) in the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA). The selected participant will join the efforts of the Division of Clinical Pharmacology 4 to utilize physiologically-based pharmacokinetic (PBPK) modeling to evaluate the impact of a combination of extrinsic and intrinsic factors. The participant will be involved with determining the impact of these factors on the systemic exposure of antiretroviral medications in HIV-1 infected patients.

The participant may be involved in one or more of the following aspects of the project:

• Evaluating the combination of hepatic impairment and transporter-related or metabolism-related drug-drug interactions.
• Evaluating clinically relevant combinations of extrinsic and intrinsic factors (e.g., renal impairment and transporter-related or metabolism-related drug-drug interactions).

The Research Participation Program for FDA is administered by the Oak Ridge Institute for Science and Education (ORISE). The initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend depending on educational level and experience. The participant must show proof of health insurance. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA or the program administrator, and there are no fringe benefits paid.

Qualifications:

• A Doctoral degree in pharmaceutical sciences (e.g., pharmacometrics, drug metabolism, pharmaceutics), engineering, or a Pharm.D. with equivalent experience, received within the last five years.
• Knowledge or familiarity with modeling and simulation software (e.g., NONMEM), and knowledge of PBPK modeling and software (e.g., SIMCYP) is desired.

How to Apply:

To be considered, please send a current CV/resume to FDArpp@orau.org. Please reference FDA-CDER-2013-0008 in all communications.