9 structures-"https:" "https:" "https:" "https:" "https:" "https:" "https:" "https:" "https:" "Univ" uni jobs at Center for Drug Evaluation and Research (CDER) in United States

FDA 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 | 2 days 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 Studying the Critical Quality Attributes of Multispecific Antibodies/Fusion Proteins (SARITA 4400)

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 2 days ago

Objectives: During the appointment, you will learn how to: Design bispecific and trispecific antibodies/fusion proteins using genetic engineering approaches while applying appropriate structural and functional

FDA Developing Novel Technologies for Identification/Characterization of Glycans on Glycoproteins

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

release from glycoprotein drugs with chemo-enzymatic methods and characterize glycan structures with state-of-the-art technologies, including H(U)PLC and mass spectrometry (MS). Learning Objectives: Under

FDA Evaluating Consumer Study Regulatory Review Approaches for Applications with Novel Digital Technologies

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 2 days ago

science research design and data analysis within a regulatory context. Learning Objectives: There will be structured weekly meetings with the mentor (the deputy division director in DNPD II) and co-mentor

FDA Clinical Pharmacology / Model Informed Drug Development

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 2 days ago

regulatory science and prepare the next generation of regulatory scientists. Learning Objectives: The fellowship combines structured learning with applied regulatory research. You will attend seminars

FDA Properties of Bayesian Hierarchical Model Estimators of Subgroup Treatment Effects

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 2 days ago

mentorship. This experience will advance your development by providing structured research training applicable to pharmaceutical and regulatory science careers, facilitating professional network development

FDA Bayesian Statistical Approaches to Address the Unique Challenges of Rare Disease Drug Development

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 2 days ago

the unique challenges of rare disease drug development. Educational activities will include mentorship from FDA biostatisticians, participation in cross-functional team meetings, and structured learning

FDA Serum Creatinine Elevation Due to Renal Transporter Inhibition

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

impairing glomerular filtration rate. Developing expertise in nephrotoxicity assessment including differentiation between functional creatinine elevation and structural kidney damage, interpretation

FDA Clinical Pharmacology of Novel Modality Biological Products

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

clinical pharmacology understanding of novel modality biological products, including novel structures, novel mechanisms of action, novel delivery methods, etc. This fellowship directly supports FDA's mission