FDA Modeling and Simulation Fellowships

How To Apply

To submit your application, scroll to the bottom of this opportunity and click APPLY.

• An application
• Transcripts –  for detailed information about acceptable transcripts
• A current resume/CV, including academic history, employment history, relevant experiences, and publication list
• One educational or professional recommendation

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 in your email.

U.S. Food and Drug Administration (FDA)

FDA-CDER-

3/30/2027 3:00:00 PM Eastern Time Zone

Applications will be reviewed on a rolling-basis.

Multiple research opportunities are currently available within the Division of Quantitative Methods and Modeling (DQMM) in the Office of Research and Standards (ORS) within the Office of Generic Drugs (OGD), located within the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) 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.

The Division of Quantitative Methods and Modeling (DQMM) in the Office of Research and Standards (ORS) within the Office of Generic Drugs (OGD) provides expertise in advanced quantitative methods for the generic drug research program and conducts regulatory science and research activities based on quantitative approaches. Some of the responsibilities residing in DQMM include providing quantitative method support for guidance development, abbreviated new drug application (ANDA) reviews, citizen petitions, controlled correspondence, pre-ANDA meetings, methodology development for bioequivalence evaluation, active ingredient sameness demonstration, and post‑marketing safety surveillance.

This Division coordinates modeling, simulation, data analysis and data mining, and establishes the scientific computing infrastructure for OGD. DQMM is also developing innovative quantitative approaches to improve regulatory decision making for generic drugs by fully utilizing the large amount of data available to FDA.

DQMM is a fast‑paced, dynamic scientific environment with opportunities to collaborate with dedicated, energetic senior researchers who want to make a difference and improve public health. We are looking for several qualified individuals to participate in research activities that support our mission of providing high quality generic drugs to the American consumer.

This research project in DQMM will provide an outstanding opportunity to learn and apply quantitative analysis, modeling, and simulation.

• Modeling and simulation of solid oral products to ensure consistency and quality of bioequivalence (BE) recommendations (e.g., physiologically based pharmacokinetic (PBPK) absorption models, in vitro‑in vivo correlations and pharmacokinetic/pharmacodynamic (PK/PD) modeling) including biowaivers.
• Modeling and simulation to reduce/replace in vivo BE studies (i.e., in vivo PK BE studies, clinical endpoint or pharmacodynamic endpoint BE studies) for complex generic products and other generic products with clinical study challenges.
• Application of PBPK and/or computational fluid dynamics models to develop new BE methods for locally acting drug products administered via non‑oral routes.
• Population PK modeling to support more effective in vivo study designs and methods for evaluating BE. This may include implementing sparse sampling schemes for oncology patient studies and developing alternative study designs for long‑acting injectable products with shorter durations or reduced sample sizes.
• PK/PD modeling of narrow therapeutic index drugs and complex drug products and clinical trial…