FDA Postdoctoral Fellowship - Clinical Pharmacology and Immunogenicity Data Assessment

How to Apply

Download the new ORISE GO mobile app in the Apple App Store or Google Play Store to help you stay engaged, connected, and informed during your ORISE experience and beyond!

All documents must be in English or include an official English translation.

If you have questions, send an email to ORISE.FDA.CDER. Please include the reference code for this opportunity.

U.S. Food and Drug Administration (FDA)

FDA-CDER-

4/30/2026 3:00:00 PM Eastern Time Zone

• Applications will be reviewed on a rolling basis.

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

This research project focuses on the systematic evaluation of immunogenicity effects on drug exposure and the investigation of anti‑drug antibody (ADA) and neutralizing antibody (NAb) assay characteristics across approved biological products. If selected, you will collaborate with FDA scientists to compile immunogenicity assessment data from multiple regulatory sources, including Biologics License Applications (BLAs), validation reports, and clinical pharmacology review documents. You will analyze assay platforms, drug tolerance parameters, positive control concentrations, and validation practices.

You will also research and analyze how immunogenicity information is communicated in FDA‑approved product labeling, comparing review findings with final labeling language to identify alignment patterns and improvement opportunities.

• Structured learning sessions on FDA’s immunogenicity guidance documents and regulatory framework
• Collaborating with experienced FDA reviewers to understand clinical pharmacology assessment methodologies
• Investigating current scientific literature and harmonization efforts in immunogenicity testing
• Analyzing complex datasets using statistical software and FDA’s analytical tools
• Learning research database design principles and data management best practices
• Contributing to development of evidence‑based recommendations for regulatory policy enhancement
• Participating in preparation of scientific presentations and written reports
• Collaborating in drafting potential updates to regulatory guidance documents
• Contributing to peer‑reviewed publications advancing regulatory science knowledge
• Experience in collaborative research within a regulatory environment
• Understanding of how regulatory science advances public health objectives

Jan‑Shiang Taur (Jan‑Shiang.

Taur.gov) and Yow‑Ming Wang (Yowming.

Wang.gov)

2026 (Start date is flexible and will depend on a variety of factors).

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

The appointment is full‑time.

Monthly stipend commensurate with educational level and experience.

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.

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  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 start date, setting forth conditions and expectations for their educational…