19 parallel-processing positions at Center for Drug Evaluation and Research (CDER)

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 16 hours ago

interpretation of clinical/model-based PK data in the context of dosing and safety; 3) Collaborate with PBPK experts both within and outside the FDA; 4) Gain an understanding of the drug regulatory review process

FDA Large Language Models (LLM) for Case Definition Classification Fellowship

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

models (LLMs) to enhance case definition processes by developing a prototype that demonstrates the capability of LLMs to accurately categorize and classify case definitions. The selected fellow will

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 | about 16 hours ago

review through an immersion into nonprescription regulations and the processes of nonprescription drug evaluation and approval. Qualitative and quantitative analytical skills will be honed. You will learn

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 16 hours ago

familiar with CDER research areas and develop interest in future careers related to the FDA's public health mission. Support includes access to an FDA-issued computer with required software and weekly mentor

FDA Dosage Optimization of Antibody-Drug Conjugates

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 16 hours ago

of dose selection of currently approved or late-stage ADCs to inform scientific and regulatory policy and processes in Office of Clinical Pharmacology (OCP). The fellow will help: Collect information

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 | about 16 hours ago

, hands-on training in MPS design, operation, and analytical evaluation. Educational activities will include: 1) Cell culture training with human mammary epithelial and endothelial cells within PDMS-based

FDA Pediatric Drug Development Programs for Drug-Device Combination Products Fellowship

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

meetings and project meetings, to better understand pediatric drug development and clinical pharmacology concepts. The fellow will be able to observe, but not participate in, the regulatory review process

FDA Clinical Pharmacology of Novel Modality Biological Products

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

. Learning Objectives: Under the guidance of the mentor, you will participate in specialized training programs covering regulatory science principles and FDA's review processes for novel biological products

FDA Computational Biology and Pharmacology Fellowship

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

, and FDA's drug evaluation processes. Additionally, you will develop competencies in data curation and analysis, understand validation criteria for alternative testing methods, and acquire knowledge