FDA Biomarker Analysis Fellowship: Bioanalysis & PD Insights

Oak Ridge Institute for Science and Education; Silver Spring (MD); On-site; USD 36,000 - 48,000; Full time

Job summary

FDA fellowship opportunity in the Office of Translational Sciences (CDER) in Silver Spring, MD, focusing on biomarker roles across BLAs from 2015 to 2025. The program offers a 12‑month, full‑time placement with a monthly stipend commensurate with education and experience.

Start date 2026, eligibility includes Master’s or Doctoral degree in Life/Health/Medical Sciences – Pharmacology. Applicants must sign the FDA Education and Training Agreement and may be open to non‑employee appointment

Qualifications

• Pursuing or have received a Master’s or Doctoral degree in Life, Health, and Medical Sciences – Pharmacology within the last five years.
• Discipline: Life, Health, and Medical Sciences – Pharmacology.

Responsibilities

• Investigate the use of biomarkers in diagnostic, pharmacodynamic, and efficacy roles across BLAs (2015–2025).
• Analyze related bioanalytical methods to identify gaps and provide scientific rationale for appropriate bioanalysis.
• Propose solutions to improve drug development efficiency.
• Navigate FDA databases and understand how biomarkers support regulatory decision-making.

Education

Master’s or Doctoral degree in Life, Health, and Medical Sciences – Pharmacology

Job description

FDA fellowship opportunity in the Office of Translational Sciences (CDER) in Silver Spring, MD, focusing on biomarker roles across BLAs from 2015 to 2025. The program offers a 12‑month, full‑time placement with a monthly stipend commensurate with education and experience.

Start date 2026, eligibility includes Master’s or Doctoral degree in Life/Health/Medical Sciences – Pharmacology. Applicants must sign the FDA Education and Training Agreement and may be open to non‑employee appointment