FDA Research Fellowship: Neurodevelopmental Assessment of Prenatal Analgesic Exposure Using Translational Models

Overview

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), located in Jefferson, Arkansas, approximately 30 miles south of Little Rock.

The Center for Drug Evaluation and Research (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 U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. These efforts cover more than just medicines.

Research Project: The participant will join a project to assess the neurotoxicity of a drug of great interest to CDER. The resulting data may impact guidelines over the use of a drug of interest in pregnancy. The National Center for Toxicological Research (NCTR) is currently investigating the developmental neurotoxic potential of an analgesic at the request of the Center for Drug Evaluation and Research (CDER).

NCTR currently has two projects underway investigating the compound in question. One focuses on histological and molecular endpoints in the guinea pig and is ongoing, while a second study investigating histological, molecular, and behavioral endpoints in the rat has just started.

Under the guidance of a mentor, the ORISE participant will be involved in most aspects of the study including experimental design, in-life data collection, endpoint validation and collection, data analysis, and data dissemination. The participant will regularly present and discuss findings at internal meetings that will include members of NCTR and CDER staff.

Learning Objectives: As a participant, you will learn numerous neurotoxicity assessment methods including histological and molecular imaging, molecular analysis methods including protein expression quantification, advanced behavioral assessments, and MRI techniques. Additionally, these studies will take a year of preparation in advance, so you will gain firsthand experience in preparing experiments. You will have the opportunity to present findings at internal and external meetings and be a part of manuscript preparation.

Throughout the project, you will gain expertise with many laboratory methods related to the analysis of neurotoxicity and the assessment of developmental endpoints in rodents. Additionally, you will learn how to assess neurotoxicity within the lab and determine if findings are of regulatory relevance.

What makes this a unique training experience is that you will gain firsthand experience performing a regulatory-style study and have access to regulators. “Regulatory-style” toxicity assessments differ from “academic” toxicity studies. The perspective of the regulator is rarely expressed outside of the regulatory institution. This opportunity for research experience and regulatory exposure is rare. As an ORISE participant involved in this project, you will gain an excellent understanding of how to generate regulatory-style toxicological data and how to evaluate the generated data in a regulatory context. Upon completion, you will have skills to pursue a career in basic neurotoxicity research, regulatory toxicity research, or in regulatory assessments.
Mentor: The mentors for this opportunity are John Talpos (john.talpos@fda.hhs.gov) and Timohty Flanigan (timothy.flanigan@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentors.

Anticipated Appointment Start Date: May 2026. 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.

Participant Stipend: The participant will receive a monthly stipend commensurate with educational level and experience.

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 the one of the relevant fields.

Degree preference:

Has received a bachelor’s or master’s degree within the past three years at the time of appointment, or;
Has received or be currently pursuing a doctoral degree.
Point of Contact
Ashley
Eligibility Requirements
Degree: Bachelor’s Degree, Master’s Degree, or Doctoral Degree.