*Applications will be reviewed on a rolling basis.

A research opportunity is available in the Office of New Drugs/ Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) located at the Office of Regulatory Affairs (ORA) Pacific Southwest Medical Products Laboratory in Silver Spring, Maryland.

Up to 42% of recently completed pediatric trials have failed to establish either safety or efficacy, with the majority failing to establish efficacy, leading to an inability to label the product for use in children. ORPURM is proposing a retrospective review and analysis of patient level data (adult and pediatric) from former new drug applications (NDAs) to explore trial design elements or conduct that may contribute to the negative findings and provide a framework for optimizing trial design for future pediatric drug development.

Under the guidance of a mentor, the participant will gain knowledge in trial design considerations that can impact response in drug development. In addition, the participant will learn about methodological features of studies, data curation and database building, data analysis, dissemination of results (presentations, publications), etc.

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.

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