FDA Research Opportunity - Dose Selection of Products for Inflammatory Bowel Disease U.S. Food and Drug Administration (FDA) in United States

This research opportunity at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) focuses on how dose selection and optimization are being used in targeted oncology therapeutics , including drugs such as tyrosine kinase inhibitors. The project is set within the FDA’s regulatory science environment in White Oak, Maryland, where CDER evaluates the safety and effectiveness of drugs used in the United States. The participant will work on a project that collects...

This postdoctoral fellowship sits within the Northeastern University–Moderna Academic–Industrial Fellowship Program and focuses on pharmacometrics in a collaborative academic–industry setting. The fellow will be embedded in Moderna’s Clinical and Quantitative Pharmacology function and contribute to modeling and simulation work that supports drug candidates across early and late stages of clinical development, across multiple therapeutic modalities. The project centers on model-informed drug deve...

FDA CDER is offering a postdoctoral fellowship in proteinuria, biologics pharmacokinetics, pharmacometrics, and modeling/simulation at the U.S. Food and Drug Administration in Silver Spring, Maryland, United States . The project aims to better understand how proteinuria affects elimination and PK of biological products, with the goal of optimizing dosing in patients and informing clinical pharmacology considerations and labeling recommendations. The fellow will contribute to data collection, ana...

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...

This research opportunity is hosted by the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) , in the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine and the Division of Pediatrics and Maternal Health in Silver Spring, Maryland. The project is based at the FDA White Oak Campus, with a hybrid format that includes some in-person participation. The opening focuses on pediatric extrapolation in drug development: using adult and pediatric ...