FDA Pharmacometrics Fellowship
*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Strategic Programs/Office of Program & Strategic Analysis at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) located in Silver Spring, Maryland.
Under the guidance of a mentor the participant may be involved in applying modeling and simulation to address specific regulatory questions for biologics. The participant will learn about exposure response of biologic drugs in clinical trials and gain knowledge of optimal trial designs. This is a great opportunity to learn the regulatory aspects of the clinical pharmacology and participate in modeling and simulation efforts for quantitative regulatory decision making.
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 six months, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. There is a full-time and part-time appointment at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
Qualifications
The qualified candidate should be currently pursuing or have received a doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2020-0544) in your email.