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Research Project Description

Renal Impairment Fellowship
Division of Clinical Pharmacology IV
Office of Clinical Pharmacology
Center for Drug Evaluation and Research
Silver Spring, MD

FDA-CDER-2014-0044

Project Description:

A fellowship opportunity is currently available in the Division of Chemical Pharmacology IV within the Office of Clinical Pharmacology (OCP) at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA).

OCP’s mission is to assure the safety and effectiveness of new drugs through the evaluation of clinical pharmacology data in support of CDER’s Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA) review programs.

The selected participant will join OCP’s efforts in providing a framework for conducting pharmacokinetic studies in subjects with renal impairment based on drug properties, especially for drugs that undergo high and intermediate metabolism. From this project, OCP aims to identify specific drug characteristics that can predict changes in exposure as a function of renal impairment.

The Research Participation Program for FDA is administered by the Oak Ridge Institute for Science and Education (ORISE). The initial appointment is for four months, 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 Master’s degree in clinical pharmacology received within the last five years. Students currently pursuing a Doctoral degree in clinical pharmacology at an accredited U.S. college or university are also encouraged to apply. Proof of enrollment will need to be provided each semester.

How to Apply:

To be considered, please send a current CV/resume to the attention of FDArpp@orau.org. Please reference FDA-CDER-2014-0044 in all communications.