22 machine-learning-"https:" "https:" "https:" "https:" "https:" "https:" "UCL" uni jobs 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 | about 18 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 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 | about 18 hours 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 Characterization of Topical Spray Drug Products

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 18 hours ago

to support regulatory activities. The participant will also learn to characterize physical characteristics of aerosol spray products using instrumentation such as laser diffraction, high-speed imaging, cascade

FDA Review of Pediatric Extrapolation and Dosage Optimization

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 18 hours ago

. Overall, this project will support the Agency’s efforts to advance pediatric oncology drug development through enhanced clinical pharmacology evaluation. Learning Objectives: During the appointment, you

FDA Development of Cell-based Reporter Assays for FSH, LH and hCG

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 18 hours ago

be utilized to test unstressed and stressed FSH, LH and hCG samples, comparing their performance with the current in-use rat potency assays. Learning Objectives: During the appointment, you will have

FDA Quality Knowledge Management Throughout the Drug Product Lifecycle

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 18 hours ago

knowledge base is dispersed and “hidden” in different parts of the Agency. Learning Objectives: Under the guidance of the mentor, the participant will train on pharmaceutical science, laws and regulations

FDA Clinical Pharmacology / Model Informed Drug Development

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 18 hours ago

regulatory science and prepare the next generation of regulatory scientists. Learning Objectives: The fellowship combines structured learning with applied regulatory research. You will attend seminars

FDA Biomarker Analysis: Addressing the Gap Between Patient Enrollment Applications and Pharmacodynamic Effect Evaluation

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 18 hours ago

early. Learning Objectives:  Under the guidance of the mentors, you will have the following learning outcomes; Learn the FDA database navigation system Learn how the biomarker assists the drug development

FDA Determination of Qualification Limits for Peptide-related Impurities of Follow-on Products to Inform Guidance

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 18 hours ago

understanding of HLA-restricted T-cell activation. Learning Objectives: Under the guidance of a mentor, you will gain experience in and learn to: Identify Impurity-Derived Neoepitopes via Immunopeptidomics Define

FDA Developing Novel Technologies for Identification/Characterization of Glycans on Glycoproteins

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 18 hours ago

release from glycoprotein drugs with chemo-enzymatic methods and characterize glycan structures with state-of-the-art technologies, including H(U)PLC and mass spectrometry (MS). Learning Objectives: Under