*Applications will be reviewed on a rolling basis.

A postdoctoral fellowship opportunity is currently available in the Office of New Drugs at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) located in Silver Spring, MD.

Research efforts will include participation in multi-disciplinary efforts in a nationally recognized training program in support of the FDA’s mission. The candidate will train closely with the Principal Investigator (PI) on ongoing and proposed research projects performing data review and extraction of relevant information from several CDER databases to support the development of computational models for placental permeability intended to assess the risk to the fetus from drugs prescribed during pregnancy. The main aim of this project is to provide reliable information about the potential for placental transfer, as well as the mechanisms of placental permeability, of drugs in order to support considering waivers for the conduct of in vivo developmental toxicology studies and/or support earlier inclusion of women of childbearing potential and pregnant women in clinical trials. The appointee will also learn various in vitro techniques for evaluation of the placental permeability of drugs. During the project, he/she will be actively encouraged to present the research at internal and external meetings and publish the findings in peer-reviewed journals. 

The desired start date is August 30th, 2023; start date is flexible.

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 appointment is up to 3 years and will be full-time. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.

Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA.  OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.

FDA Ethics Requirements

If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA.   For additional requirements, see FDA Ethics for Nonemployee Scientists .

FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency.  This agreement covers such topics as the following:

• Non-employee nature of the ORISE appointment;
• Prohibition on ORISE Fellows performing inherently governmental functions;
• Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
• The fact that research materials and laboratory notebooks are the property of the FDA;
• ORISE fellow’s obligation to protect and not to further disclose or use non-public information.