20 structures "https:" "https:" "https:" "https:" "https:" "https:" "https:" "https:" "Univ" positions at Center for Drug Evaluation and Research (CDER)

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 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 | 2 days 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 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 Evaluating Time-Course of Anti-Drug Antibodies for Therapeutic Proteins Fellowship

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

regulatory assessments, and strengthen critical-thinking and scientific communication skills to support evidence-based decision-making in drug development. Under the guidance of a mentor, structured learning

FDA Postdoctoral Fellowship - Clinical Pharmacology and Immunogenicity Data Assessment

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

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

FDA Clinical Research Fellowship

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

on how co-use should be evaluated for impairment. Learning Objectives: The fellowship will provide structured learning opportunities in clinical pharmacology, pharmacokinetics, regulatory science

FDA Fellowship - In Silico and In Vitro Approaches to Inform Polypharmacy and Patient Effects on Opioid Overdose

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

high-volume data to prepare for modeling; Learn how to adjust model structures/parameters based on calibration data, and evaluate model credibility using validation data; Learn how to execute modeling