FDA Postdoctoral Fellowship on the Clinical Efficacy of Targeted Breast Cancer Drugs

*Applications will be reviewed on a rolling-basis.

A postdoctoral research opportunity is currently available with the Office of Commissioner (OC), Office of Women's Health (OWH), U.S. Food and Drug Administration (FDA). The project will be located at the Center for Drug Evaluation and Research (CDER) in the Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, U.S. Food and Drug Administration (FDA) located in Silver Spring, Maryland. 

We are interested in applying quantitative clinical pharmacology to address specific challenges in drug development and patient care. In this research project, we propose developing data-driven and scientifically-based regulatory recommendations to assess: the appropriate measurement of relative dose intensity and the impact of dosage interruptions/reductions on efficacy of breast cancer drugs. The outcomes from this project are expected to guide rational selection of appropriate dosage modification strategies to enhance treatment adherence and minimize the impact on treatment clinical effects in patients with breast cancer.

Under the guidance of a mentor, the participant will be learning modeling and simulation techniques, and regulatory and clinical knowledge in drug development.

Anticipated Appointment Start Date: September 2023; 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 12 to 24 months 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

Qualifications

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

Preferred Skills:

• Knowledge of clinical pharmacology, PK/PD modeling principles, and statistics
• Familiarity with modeling and simulation software
• Good oral and written communication skills
• Strong quantitative and statistical skills