FDA Fellowship - Clinical Pharmacology Considerations for Novel Therapeutic Modalities

*Applications will be reviewed on a rolling-basis.

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

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: This research project addresses critical knowledge gaps in emerging therapeutic modalities, specifically immune cell engagers and radioligand therapies, where limited literature and no clinical pharmacology guidance exists due to their novelty and rapid evolution. The research aims to facilitate product development, assist review decision-making, identify regulatory knowledge gaps, and support evidence-based evaluation approaches. The selected participant will engage in comprehensive research training activities focused on systematically analyzing novel therapeutic modalities through database investigation, literature review, and regulatory documentation analysis. The participant will contribute to building knowledge database and developing review tools that support regulatory science advancement and review decision for emerging therapeutic classes.

Learning Objectives: The fellowship integrates five key training areas: (1) FDA systems training in DARRTs and Docubridge navigation; (2) regulatory knowledge development through attendance at FDA meetings; (3) research methodology training under experienced scientist mentorship; (4) scientific communication skills through presentations and manuscript contributions; and (5) novel modality expertise through hands-on analysis and mentor guidance.

Under the guidance of a mentor, you will enhance comprehensive knowledge of drug development processes, regulatory decision-making, clinical pharmacology principles, and FDA review procedures while gaining practical experience with novel therapeutic modalities. You will improve critical thinking capabilities and develop essential professional competencies in research methodology, data analysis, scientific presentation, and manuscript writing skills that support career advancement in regulatory science, pharmaceutical development, or academic research.

Mentor: The mentors for this opportunity are Qin Sun (Qin.Sun@fda.hhs.gov) and Yow-Ming Wang (Yowming.Wang@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentors.

Anticipated Appointment Start Date: March/April 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.