Regulatory Research Fellow: Pediatric IBD Dose Optimization

Oak Ridge Institute for Science and Education; White Oak (MD); On-site; USD 40,000 - 65,000; Full time

Job summary

Oak Ridge Institute for Science and Education offers a research fellowship with the FDA, CDER, in White Oak, MD, focused on optimizing pediatric dose selection for IBD. The project highlights regulatory science, model-informed approaches, and collaboration with FDA mentors.

Fellows will survey programs, analyze reviews and literature, and compare adult vs pediatric dosing to inform regulatory decisions. Appointment is full time with a stipend commensurate with education and experience.

Qualifications

• Master's or Doctoral degree in a relevant field such as data science, pharmacology, or regulatory science.
• Strong analytical and data interpretation skills with regulatory context.
• Familiarity with pediatric drug development or IBD is a plus.

Responsibilities

• Survey clinical development programs for IBD products and dose-selection strategies.
• Collect and analyze data from FDA reviews and published literature.
• Compare doses between adult and pediatric populations across indications.
• Investigate how patient factors affect PK/PD and dose selection.
• Identify best practices and gaps to support regulatory decision-making.

Education

Master's Degree or Doctoral Degree

Job description

Oak Ridge Institute for Science and Education offers a research fellowship with the FDA, CDER, in White Oak, MD, focused on optimizing pediatric dose selection for IBD. The project highlights regulatory science, model-informed approaches, and collaboration with FDA mentors.

Fellows will survey programs, analyze reviews and literature, and compare adult vs pediatric dosing to inform regulatory decisions. Appointment is full time with a stipend commensurate with education and experience.