A complete application consists of:

• An application
• Transcripts – Click here for detailed information about acceptable transcripts
• A current resume/CV, including academic history, employment history, relevant experiences, and publication list
• Two educational or professional references

All documents must be in English or include an official English translation.

If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.

An opportunity is available at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) in Silver Spring, Maryland.

This project investigates multiple patient factors, alone or in concert, and their effect on drug disposition (for example: age, gender, genetics, organ dysfunction, drug-drug interactions, etc). Under the guidance of a mentor, the participant will learn about policy evaluations that will advance new drug development and promote therapeutic individualization. The candidate will engage with the mentor in regulatory science research efforts to support development of both scientific and regulatory policy for the Office of Clinical Pharmacology. Activities may include literature review, analysis of existing and proposed policy, and/or construction of a knowledge base to store research data and inform further investigations.

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.

The qualified candidate must have received a PhD, PharmD, and/or MD level degree in a health-related STEM field. Degree must have been received within five years of the appointment start date. A preferred candidate is one that has analytical skills and has great interest in advance regulatory science and public health.

• Degree: Doctoral Degree received within the last 60 month(s).
• Discipline(s):
  • Life Health and Medical Sciences (1 )