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Research Project Description

Pharmacokinetic/Pharmacodynamic Study Design Assessment Fellowship
Office of Clinical Pharmacology
Office of Translational Sciences
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Silver Spring, MD

FDA-CDER-2014-0056

Project Description:

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

OCP aims to assure the safety and effectiveness of new drugs through the evaluation of clinical pharmacology and biopharmaceutics data in support of CDER’s Investigational New Drug, New Drug Application and Biologics License Application review programs. Through research, we assure that regulatory policy and decision-making are based on the best available science.

Under the guidance of a mentor, the selected participant will be involved in optimizing the trial design and criteria for pharmacokinetic (PK)-pharmacodynamic (PD) studies for establishing biosimilarity. The project will address dose selection, study design features (i.e., single versus multiple dose, etc.), PK-PD measures and their statistical comparison.

This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. 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 commensurate with education level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at CDER 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 clinical pharmacology, PK-PD or a related field received within the last five years. Students currently pursuing a Doctoral degree in the aforementioned areas are also encouraged to apply. Proof of enrollment will need to be submitted each semester.
  • Experience and/or knowledge in statistics, and modeling and simulation using software (i.e., NONMEM, SAS, Splus/R, etc.) is desired.

How to Apply:

To be considered, please send a current CV/resume to the attention of FDArpp@orau.org. Please reference FDA-CDER-2014-0056 in all communications.