*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Translational Sciences/ Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
This project will evaluate the application of modeling and simulation approaches and pediatric clinical pharmacology data to inform the risk assessment of a drug for breastfeeding children.
Under the direction and guidance of a mentor, the participant will have the opportunity to learn the application of physiologically based pharmacokinetic modeling (PBPK) models in maternal and pediatric clinical pharmacology. In addition, the candidate will learn maternal and pediatric clinical pharmacology principles and the impact on drug disposition in the relevant specific populations.
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 educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time 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.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity (FDA-CDER-2021-0626) in your email.