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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
• One educational or professional recommendation

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.

*Applications will be reviewed on a rolling basis.

A research opportunity is currently available with the Office of Translational Sciences/ Office of Clinical Pharmacology (OCP) at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) located in Silver Spring, Maryland. CDER performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the FDA, CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.

The project will examine issues related to scientific and regulatory best practices in the dose selection and optimization, therapeutic individualization, and benefit/risk balance in patient subpopulations. The project will help inform the development of both scientific and regulatory best practices in therapeutic individualization and model informed drug development.

Under the guidance of a mentor, the participant will learn how to incorporate clinical pharmacology principles into therapeutic individualization and drug development. The participant will also learn how to design and propose regulatory research; then conduct and summarize the study results.

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.

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 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.

The qualified candidate should be currently pursuing or have received a master's or doctoral degree in one of the relevant fields. Degree must have been received within the past five years.

Preferred Skills and Knowledge:

• Prior research knowledge and data analysis skills
• Conducting comprehensive searches of the medical literature and organizing results
• Creating spreadsheets and/or databases (e.g. Excel, Access) to collect extracted data
• Strong written and oral communication skills
• Have a profound interest in leading projects that advance regulatory science and public health

• Degree: Master's Degree or Doctoral Degree received within the last 60 months or currently pursuing.
• Discipline(s):
  • Computer, Information, and Data Sciences (17 )
  • Engineering (1 )
  • Life Health and Medical Sciences (48 )
  • Mathematics and Statistics (11 )
  • Social and Behavioral Sciences (29 )

Have you lived in the United States for at least 36 out of the past 60 months? (36 months do not have to be consecutive.)