FDA Modeling and Simulation Fellowships

How To Apply

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

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

• 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

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

Final date to receive applications: 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 CDER performs an essential public health task by ensuring that safe and effective drugs are available to improve the health of people in the United States.

The DQMM provides expertise in advanced quantitative methods for the generic drug research program and conducts regulatory science and research activities based on quantitative approaches, including 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 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, including 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 simulation to aid risk‑based BE evaluation.
• Build data infrastructure and analysis tools to increase ANDA review efficiency and quality.
• Use and development of artificial intelligence (AI), machine learning (ML) and large language models (LLMs) to help promote business intelligence in the Agency (e.g., interactive AI expert systems).
• Integration of AI/ML models with conventional/mainstream PK modeling to improve the modeling efficiency (e.g., automatic PK model selection, ML based survival analysis, etc.).
• Applications and development of data analytic approaches to support complex generic drug product development and regulatory assessment, e.g., whole profile comparison, multivariate analysis, etc.

The mentor for this opportunity is Andrew Babiskin (Andrew.Babiskin.gov). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment

Start Date:

March/April 2026 (flexible).

Appointment Length:
Initially for one year, may be renewed upon recommendation of FDA and contingent on the availability of funds.

Level of Participation:
Full‑time.

Participant Stipend:
The participant will receive a monthly stipend commensurate with…