FDA Fellowship - Optimization of Drug-induced Liver Injury Analysis Methods

*Applications will be reviewed on a rolling-basis.

FDA Office and Location: A research opportunity is available immediately within the Office of Drug Evaluation Sciences (ODES), Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) located in Silver Spring, Maryland.

Research Project: Through this research project, you will investigate and optimize drug-induced liver injury (DILI) analysis methods to address poor data quality issues. Training activities will include collating DILI subjects from 2024 approved NDAs/BLAs, analyzing MedDRA preferred terms, and examining racial/ethnic representation in clinical trials. Under the guidance of a mentor, you will also receive training in regulatory review processes, data quality assessment methodologies, statistical analysis of rare adverse events, and understanding of health disparities in clinical research.

Learning Objectives: You will develop skills in safety signal detection, learn to identify data quality issues that could obscure safety signals, and understand challenges in identifying rare adverse events in minority populations. Through this fellowship, you will gain experience in regulatory science applications, develop analytical skills for drug safety assessment, and contribute to enhancing reliability of DILI signal assessment methods.

Mentor: The mentors for this opportunity are Jinzhong Liu (Jinzhong.Liu@fda.hhs.gov) and Aaron Waddell (Aaron.Waddell@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentors.

Anticipated Appointment Start Date: 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.