19 machine-learning "https:" "https:" "https:" "https:" "https:" "https:" "https:" "UCL" "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 20 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 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 20 hours ago

science research design and data analysis within a regulatory context. Learning Objectives: There will be structured weekly meetings with the mentor (the deputy division director in DNPD II) and co-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 20 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 20 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 20 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 Clinical Pharmacology / Model Informed Drug Development

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

FDA Dosage Optimization of Antibody-Drug Conjugates

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

. Contribute to a manuscript regarding the results of the project. Learning Objectives: The fellow will gain regulatory science experience and policy development insight that supports advancement in clinical

FDA Serum Creatinine Elevation Due to Renal Transporter Inhibition

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

that provide clarity on distinguishing transporter-mediated creatinine elevation from true nephrotoxicity in drug development and regulatory review. Learning Objectives: Educational activities will at least