Jobs

FDA Prediction of Drug Mammary Excretion Fellowship

Posted on: August 28, 2020 Apply Now
Fellowships and Graduate School Expires March 31, 2021

*Applications will be reviewed on a rolling-basis.

A research opportunity is available in the Office of Translational Sciences/Office of Clinical Pharmacology, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.

The Office of Clinical Pharmacology (OCP) Division of Cardiometabolic and Endocrine Pharmacology (DCEP) evaluates clinical pharmacology protocols and data submitted in INDs/NDAs/BLAs. This project in OCP will develop an in vitro human mammary epithelial cell model and drug classification system to predict the amount of drug transferred into human milk. If this project is successful, the in vitro cell permeation model is expected to support breastfeeding risk assessment and labeling for some specific classes of drugs.

Under the guidance of a mentor, the participant will train on collecting human mammary drug excretion data, developing a drug classification system based on drug physiochemical properties, and developing an in vitro-in vivo extrapolation (IVIVE) approach. The research is beneficial to our public health mission and will prepare the participant for a successful career transition into regulatory science research.

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.

The Homeland Security Presidential Directive-12 (HSPD-12) mandates a background check be completed for both U.S. Citizens and foreign nationals. Foreign nationals must have resided in the U.S. for at least three (3) of the past five (5) years in order for FDA to be able to complete a background check.

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.

If you have questions, send an email to ORISE.FDA.CDER@orau.org.

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