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FDA Drug Development in Oncology Clinical Trials

*Applications will be reviewed on a rolling-basis. Early submission of applications is strongly encouraged. A selection may be made at any time during the review process.

An opportunity is available at the U.S. Food and Drug Administration (FDA), Office of the Commissioner (OC), Oncology Center of Excellence (OCE) located in Silver Spring, Maryland.

Under the guidance of a mentor, the participant will be involved in the following project activities:

  • Analyze pooled data from cancer clinical trials that evaluated PD-1 inhibitors in PD-1 inhibitor-native patients and were submitted to FDA
  • Participate in conducting research to identify and characterize factors--such as patient and disease factors, at baseline and longitudinally, and PD-1 inhibitor treatment history--associated with unconventional tumor response patterns (pseudoprogression) as well as PD-1 resistance
  • Engage with drug development stakeholders to identify opportunities for a harmonized approach to characterizing PD-1 inhibitor resistance to advance oncology drug development in this high unmet medical need population

Anticipated Appointment Start Date: July 1, 2021; 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 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.OC.other@orau.org. Please include the reference code (FDA-OCE-2021-04) for this opportunity in your email.