47 security-"https:" "https:" "https:" "https:" "UCL" positions at Center for Drug Evaluation and Research (CDER)

FDA Dosage Optimization of Antibody-Drug Conjugates

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 6 days ago

drug-antibody ratios, along with how these characteristics influence therapeutic efficacy and safety profiles. Understand dose-finding methodologies, including dose escalation and expansion strategies

FDA Dosing of Cancer Drugs in Obesity

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 6 days ago

clinical trials to examine dosing, efficacy outcomes, and safety profiles across different body mass index categories, and investigate the relationship between body size (body weight, body mass index, body

FDA Clinical Pharmacology of Novel Modality Biological Products

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 6 days ago

of ensuring safety and efficacy of innovative therapeutic modalities. You will investigate pharmacokinetic and pharmacodynamic characteristics of novel biological products through systematic literature reviews

FDA Over the Counter Drug Monograph Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 6 days ago

: Conduct literature searches on specific monograph drug active ingredients using regulatory science databases and evaluate scientific evidence supporting safety and effectiveness determinations. Data

FDA Modeling and Simulation Fellowships

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 6 days ago

evaluation, active ingredient sameness demonstration, and post marketing safety surveillance. This Division coordinates modeling, simulation, data analysis and data mining, and establishes the scientific

FDA Computational Biology and Pharmacology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 6 days ago

) into safety endpoints (such as cardiotoxicity, immunogenicity, etc.) Learning Objectives: As a participant, you will have structured learning opportunities in regulatory science, computational toxicology, and

FDA Fellowship - Statistical Methods for Three-Arm Clinical Trials with Multiple Testing Procedure

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 1 month ago

to conducting reviews of drug safety or efficacy and from participating in employee staff meetings to ensure compliance with fellowship guidelines. The participants are encouraged to contribute to educational