FDA Regulatory Analysis of Dose-Finding and Optimization Approaches in Targeted Oncology Therapeutics 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) is based in White Oak, Maryland and focuses on improving dose selection for products used in inflammatory bowel disease (IBD). The project sits within FDA’s regulatory science environment, where the goal is to support safer and more effective pediatric therapeutics through better evidence on dosing. The fellow will examine how dose-selection strategies have been used in clinic...

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 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...

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...

The University of California, Irvine Department of Emergency Medicine is accepting applications for a Postdoctoral Scholar position in the School of Medicine. This is a pool advertisement for qualified candidates who will join research activity within Emergency Medicine at UCI. The opportunity is based in a clinical academic environment focused on Emergency Medicine, offering a postdoctoral research appointment at the University of California, Irvine. The department invites applicants with docto...