FDA Neuropsychiatric Clinical Pharmacology Fellowship

Overview

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is available in the Office of Translational Sciences (OTS), Office of Clinical Pharmacology (OCP) at the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), 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.

Research Project: The research project will involve systematic review of clinical trials used to inform the past approval of drugs to treat neurological conditions and explore the differences in sex- and other demographic characteristics in drug exposures, pharmacodynamic biomarkers, clinical efficacy and safety outcomes. Additional areas of research include the use of quantitative clinical pharmacology approaches to understand the sex-differences in placebo-response, exposure-biomarker-response, and exposure-response for efficacy/safety and its potential implications in designing and conducting future clinical trials.

Learning Objectives: Under the guidance of the mentor, the participant will have the opportunity to collaborate with cross-disciplinary team of FDA scientists and engage in discussions related to the key research questions outlined above. The participant will collect and analyze available data, e.g., multidisciplinary regulatory reviews of approved therapies, publicly available sources such as research and review articles from literature. The participant will also have the opportunity to engage with internal- and external- stakeholders and present the findings.

Anticipated Appointment Start Date: 2024.  Start date is flexible and will depend on a variety of factors.

Appointment Length: The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.

Level of Participation: The appointment is full time.

Citizenship Requirements: This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.

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 participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. 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 Ethics Requirements

If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists.

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 bachelor’s, master’s, or doctoral degree in one of the relevant fields. Degree must have been received within the past five years.

Preferred skills:

Experience with quantitative analysis methodologies is preferred.