28 Design-"https:"-"https:"-"https:"-"https:"-"https:" Fellowship positions at Center for Drug Evaluation and Research (CDER)

FDA Fellowship - Applied Regulatory Science In Vitro Molecular Assay Development

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 15 hours ago

. This will include experimental design, testing and analysis of molecular changes associated with drug exposure, application of classical and advanced molecular biology techniques for gene expression and

FDA Fellowship - Systematic Evaluation of Factors Affecting Disease Progression, Pharmacodynamics and Treatment Response in Neurodegenerative Conditions

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 16 hours ago

treatment options, clinical trial designs, and drug development approaches. Gain expertise in data collection & handling, database building, and various contemporary data exploration/analyses techniques

FDA Postdoctoral Fellowship - Advancing Regulatory Science through Real-World Evidence: Synthesis, Gap Analysis, and Strategic Direction

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

) demonstration project portfolio Conduct a comprehensive review of completed and ongoing demonstration projects across key domains (data considerations, study design, and analytic methods) to identify common

FDA Postdoctoral Fellowship: Infrastructure and Methods Development for Sustainable Real-World Evidence Monitoring

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

to assess the quality, reliability, and regulatory utility of real-world evidence submissions in support of drug approval and post marketing requirements. Design and implement health informatics workflows and

FDA Postdoctoral Fellowship - Applied Regulatory Science Immunology

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

of the project: Experimental design, testing and assessment of biologics, biosimilars and generics Multi-parameter flow cytometry ELISA (MSD & Luminex), ELISpot, cell isolation & culture Developing/testing

FDA Research Fellowship: Neurodevelopmental Assessment of Prenatal Analgesic Exposure Using Translational Models

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | about 2 months ago

design and interpretation, in-life data collection, endpoint validation, data analysis, and dissemination of results. You will also regularly present and discuss findings at internal meetings attended by

FDA Postdoctoral Fellowship: Infrastructure and Methods Development for Sustainable Real-World Evidence Monitoring

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

to assess the quality, reliability, and regulatory utility of real-world evidence submissions in support of drug approval and post marketing requirements. Design and implement health informatics workflows and

FDA Fellowship - Consistent Approach to Maximum Daily Dose Determination

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

CDER office decisions, and existing regulatory databases. Learn to create and propose a consistent, science-based approach for determining and documenting MDD values. Learn to design and implement a

FDA Fellowship - Evaluating Approaches for Synthetic Data Generation and Evaluation in Regulatory Submissions

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

designing and applying a reproducible evaluation framework using quantitative metrics — such as Jensen-Shannon divergence, Wasserstein distance — to assess synthetic clinical data quality using publicly

FDA Fellowship - Applying Large Language Models (LLM) in Drug Safety Reviews

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

to develop prompts and design benchmark and validation studies to assess performance in additional literature review tasks. Research multi-step processes and agentic models, including comparisons with single