13 structures "https:" "https:" "https:" "https:" "https:" "University of Kent" research jobs at Center for Drug Evaluation and Research (CDER)

FDA Postdoctoral Fellowship / Research Fellowship: Enhancing the Review of Mediation Analyses—Developing a Regulatory Checklist and AI Support Tool

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 19 hours ago

analyses in clinical trial submissions to the U.S. Food and Drug Administration (FDA). The project focuses on developing a structured framework to guide statistical reviewers in evaluating mediation analyses

FDA CDER Regulatory Science Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 19 hours ago

the structure and content of internal regulatory science databases Gain familiarity with accepted regulatory science data management and governance procedures Help develop tools to visualize trends and analyses

FDA Application of AI for Precision Medicine Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 19 hours ago

/ML can uncover patterns across regulatory submission data to enhance understanding of drug response variability. Key training activities will include how to: 1) Curate and preprocess structured and

FDA Computational Toxicology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 19 hours ago

drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. Research Project: This research project aims to develop quantitative structure-activity relationship

FDA High-resolution Analytics Fellowship for Oligonucleotide Therapeutics

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 19 hours ago

other modern analytical techniques to perform structural characterization of oligonucleotides. You will learn to employ a higher-dimensional analytical platform for analyzing complex molecules. Laboratory

FDA Computational Biology and Pharmacology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 19 hours ago

for predictive model validation, and developing AI, statistical, or mechanistic models to translate nonclinical data (such as chemical structures, sequences, and in vitro functional assays for specific drugs

FDA Regulatory Science Research Project Related to Safety of Medications in Pregnancy in the Post Approval Setting

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 19 hours ago

addresses the need to improve data collection in pregnant and lactating women. Learning Objectives: This appointment provides structured learning through FDA courses and training on drug development topics

FDA Postdoctoral Fellowship in the Application of Microphysiological Systems to Study the Blood-Milk Barrier

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 19 hours ago

drug exposure and contribute to the FDA’s ongoing efforts to ensure the safety of medications used during lactation. Learning Objectives: Under the guidance of the mentor, you will receive structured

FDA Postdoctoral Fellowship - Clinical Pharmacology and Immunogenicity Data Assessment

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 19 hours ago

components and research activities will include: Structured learning sessions on FDA's immunogenicity guidance documents and regulatory framework Collaborating with experienced FDA reviewers to understand

FDA Research Fellowship: Biologic Products and the Regulatory Evaluation of Biosimilars

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 19 hours ago

) learn about biologic products and the regulatory evaluation of biosimilars; 2) use AI/ML to model relationships between molecular structures, biological responses, and clinical outcomes; 3) assess