39 development-"https:"-"https:" Fellowship research jobs at Center for Drug Evaluation and Research (CDER)

FDA Fellowship in Development and Control of Cell Free Manufacturing Platform Technologies

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours ago

synthesis (CFPS) utilizing mammalian and prokaryotic extracts. This is a developing manufacturing technology that enables the rapid, decentralized, and on-demand production of life-saving therapeutics and

FDA Fellowship - Applied Regulatory Science In Vitro Molecular Assay Development

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 20 hours ago

knockdown, cell isolation and culture, development and testing of cell-based models, data analysis, literature review, and manuscript preparation. Learning Objectives: Under the guidance of an FDA mentor, you

FDA Fellowship - Digital Health Technologies in Drug Development: Endpoint Analysis, Regulatory Guidance Comparison, and Systematic Literature Review

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

drug development by examining how digitally-derived endpoints are designed, validated, and implemented across clinical trials, therapeutic areas, and patient populations through systematic review

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

Team in developing and validating optimized workflows and analytical methods to improve efficiency, consistency, and scalability of RWE submission monitoring and public reporting. Contribute to creation

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

Team in developing and validating optimized workflows and analytical methods to improve efficiency, consistency, and scalability of RWE submission monitoring and public reporting. Contribute to creation

FDA Fellowship: Food Effect Evaluation for Oncology Drugs

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours ago

will have the opportunity to contribute to advancing FDA's mission of protecting and promoting public health through evidence-based regulatory decision-making in oncology drug development. You will also

FDA Fellowship in Mechanistic Modeling and Clinical Data Analysis of Emerging Drugs

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 20 hours ago

opioid overdose spaces. Under the guidance of a mentor, you will help in the development of quantitative systems pharmacology models and become efficient in using various computing languages, such as R, C

FDA Fellowship in Statistical Methods for New Approach Methodologies (NAMs)

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours ago

Objectives: Upon completion of this fellowship, you will have gained the following competencies and practical experiences: Develop proficiency in statistical methods for evaluating parallelism of dose-response

FDA Fellowship in Regulatory Science Advancement for Continuous Glucose Monitoring (CGM) Endpoints

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours ago

characteristics such as time above/below glycemic target ranges and glycemic variability measures, develop or adapt missing data methods for count-based or overdispersed discrete endpoints such as hypoglycemia

FDA Fellowship in Nasal and Pulmonary Drug Delivery and In Vitro Permeability Research

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours ago

to the development of alternative bioequivalence approaches for generic products that are not qualitatively and quantitatively the same as their respective reference products. Under the guidance of FDA mentors, you