25 evolution "https:" "https:" "https:" "https:" "https:" "https:" "University of Minho" uni jobs at Center for Drug Evaluation and Research (CDER)

FDA Serum Creatinine Elevation Due to Renal Transporter Inhibition

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

safety evaluators to discuss findings and their implications for regulatory policy development and review practices. Presenting research findings to the Division of Clinical Pharmacology and other

FDA Advanced Evaluation of Postmarket Product Quality Reports

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

product quality signals. During the appointment, you will help explore important parameters in cluster and/or trend identification to help with the development of an algorithm that can be used for signal

FDA Properties of Bayesian Hierarchical Model Estimators of Subgroup Treatment Effects

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 2 hours 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 Dosage Optimization of Antibody-Drug Conjugates

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

products and development programs. Participate in discussions with the Division of Cancer Pharmacology (DCP) leadership, clinical pharmacology reviewers, and team leads regarding how the results

FDA Dosing of Cancer Drugs in Obesity

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

to the development of evidence-based guidance for oncology drug dosing in patients with obesity. Gain hands-on experience with data analysis/platforms and knowledge of regulatory science and oncology drug development

FDA Artificial Intelligence and Open-Source Data for Advanced Quality Surveillance

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

generic drugs. This effort covers more than just medicines. Research Project: With the development of Artificial Intelligence and Open-Source Data for Advanced Quality Surveillance, the Office of Quality

FDA Evaluating the Pharmacokinetic Profile of Long-Acting Injectables in Pregnant Individuals

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

to drugs in the breastfed infant. This project focuses on development of PBPK models for LAI drug products (e.g., antiretroviral drugs and psychiatric drug products). The anticipated project outcomes

FDA Research Opportunity - Analysis of Patient Diversity and Ineligibility Rates in Cancer Pivotal Clinical Trials

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

presentations, and gain experience in addressing health equity issues in drug development. You will develop skills in analyzing clinical trial diversity, understanding regulatory requirements for demographic

FDA Regulatory Analysis of Dose-Finding and Optimization Approaches in Targeted Oncology Therapeutics

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

clinical data from multiple sources within FDA's information systems. You will gain regulatory science experience and policy development insight that supports advancement in clinical pharmacology, drug

FDA Research Opportunity - Dose Selection of Products for Inflammatory Bowel Disease

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

development for inflammatory bowel disease (IBD). Since the approval of infliximab for Crohn’s disease in 1998, multiple advanced therapies—including ten biologics and four small molecules—have been approved