FDA Fellowship in Quantitative Regulatory Science: Integrating Nonclinical and Clinical Data to Support Targeted Therapy Development U.S. Food and Drug Administration (FDA) in United States

This fellowship at the U.S. Food and Drug Administration’s Center for Devices and Radiological Health places participants in a regulatory science research environment focused on artificial intelligence and machine learning for medical devices. The project addresses the safety and effectiveness of AI/ML-enabled devices across healthcare uses such as image processing, disease detection, diagnosis, and therapeutic monitoring. Working under FDA mentorship, the fellow will engage with research challe...

This postdoctoral fellowship is hosted by the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) in Silver Spring, Maryland. The project is centered on understanding how proteinuria affects the elimination and pharmacokinetics of biological products, with the goal of improving dose optimization for patients in clinical studies and informing labeling recommendations. The fellow will contribute to data collection, analysis, modeling, and simulation in a regulatory s...

This fellowship is based in the Division of Quantitative Methods and Modeling within the FDA’s Center for Drug Evaluation and Research in Silver Spring, Maryland. The group works on regulatory science and quantitative research that supports the development and review of generic drugs, with a strong emphasis on modeling, simulation, data analysis, and data mining for public health decision-making. Participants will join research activities spanning a wide range of modern quantitative approaches f...

This research opportunity is based in the Office of Immunology and Inflammation , Office of New Drugs , Center for Drug Evaluation and Research at the U.S. Food and Drug Administration in Silver Spring, Maryland. The project focuses on the statistical evaluation of TD50 and benchmark dose approaches for deriving acceptable intakes of carcinogenic impurities. The appointed participant will use simulation studies to examine how these approaches perform and to help build a stronger statistical basi...

This research opportunity is offered by the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), in Silver Spring, Maryland. The project is centered on pharmacodynamic biomarkers and their growing role in drug development and regulatory decision-making. The selected participant will examine how pharmacodynamic biomarkers are being used in the evaluation of new drugs, including target engagement, dose selection, patient selection, safety monitoring, exposure-re...