29 computer-security "https:" "https:" "https:" "https:" "https:" "https:" "https:" "Dr" "Dr" uni jobs at Center for Drug Evaluation and Research (CDER)

FDA Enhancing the Review of Mediation Analyses: Developing a Regulatory Checklist and AI Support Tool

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

—an international consensus guideline that promotes transparency and reproducibility in mediation analyses (JAMA 2021;326(11):1045–1056; https://jamanetwork.com/journals/jama/fullarticle/2784353 )—as the

FDA Studying the Critical Quality Attributes of Multispecific Antibodies/Fusion Proteins (SARITA 4400)

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

trispecific fusion proteins. Using breast and ovarian cancer cell models, you will help develop bioassays to evaluate and improve the quality, safety, and anti-tumor activity of FDA-regulated products. Learning

FDA Risk Assessment of Contaminants for Supply Chain Risks

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

focusing on injection, otic, and ophthalmic drug products.  You will gain experience evaluating the safety and manufacturing considerations of generic drug products approved in multiple jurisdictions and

Comparing Neonatal Adverse Drug Events from the Literature with FDA Labels

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

the Pediatric Research Equity Act, exceedingly few drug development programs include neonates. As a result, a relatively small number of drugs have the safety and efficacy data necessary to support

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

advanced computational tools under mentorship guidance, and exploring how statistical innovations can enhance regulatory assessments of drug safety and efficacy. Developing expertise in Bayesian hierarchical

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

/product-related impurities) may alter immunogenicity risk and affect safety, pharmacokinetics, pharmacodynamics, and efficacy. Current FDA guidance (e.g., the 2021 guidance for certain highly purified

FDA Over the Counter (OTC) Drug Product Regulatory Analysis of Microbial Risks: Case Study on Ophthalmic Eye Drops

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

ability to protect public health by supporting evidence-based approaches to ensure safety through improved labeling and/or packaging recommendations that reduces consumer misuse and prevents infections

FDA Clinical Pharmacology / Model Informed Drug Development

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

are made for nucleotide-based therapeutics—such as antisense oligonucleotides, siRNA, and mRNA—intended for neurological diseases. The you will help investigate how safety margins, nonclinical data

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

extrapolating safety and efficacy data from adults to pediatrics. Mentor: The mentor for this opportunity is Suryatheja Ananthula (suryatheja.ananthula@fda.hhs.gov ). If you have questions about the nature

FDA Dosage Optimization of Antibody-Drug Conjugates

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

drug-antibody ratios, along with how these characteristics influence therapeutic efficacy and safety profiles. Understand dose-finding methodologies, including dose escalation and expansion strategies