FDA Biomarker Analysis: Addressing the Gap Between Patient Enrollment Applications and Pharmaco[...]

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

Organization: U.S. Food and Drug Administration (FDA)

Office and Location: Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), Silver Spring, Maryland.

Research Project

Investigate the use of biomarkers in multiple roles—diagnostic, pharmacodynamic, and efficacy—across biologics license applications (BLAs) approved from 2015 to 2025. Analyze the associated bioanalytical methods to identify gaps, provide scientific rationale for appropriate bioanalysis, and propose solutions to improve drug development efficiency.

Learning Objectives

• Navigate the FDA database system.
• Understand how biomarkers support drug development.
• Master bioanalysis of pharmacodynamic biomarkers and industry best practices.
• Appreciate the scientific considerations in regulatory decision‑making.

Mentors

Xiulian Du ([e-mail]) and Yow‑Ming Wang ([e-mail]).

Appointment Details

• Start date: 2026 (flexible).
• Length: initially 12 months, may be renewed upon recommendation and availability of funds.
• Level of participation: full‑time.
• Stipend: monthly stipend commensurate with educational level and experience.

Citizenship Requirements

Open to U.S. citizens, lawful permanent residents (LPR), and foreign nationals. Non‑U.S. citizens must meet the immigration status criteria outlined on the program website.

Education and Training Agreement

Applicants must read and sign the FDA Education and Training Agreement within 30 days of their start date. The agreement covers topics including the non‑employee nature of the appointment, prohibition on performing inherently governmental functions, intellectual property rights, and confidentiality obligations.

• Non‑employee nature of the appointment.
• Prohibition on performing inherently governmental functions.
• Obligation to convey FDA rights to intellectual property created during the fellowship.
• Property of research materials and laboratory notebooks.
• Protection and non‑disclosure of non‑public information.

Qualifications

Candidate must be pursuing or have received a Master’s or Doctoral degree in a relevant field within the last five years of the appointment start date.

Eligibility Requirements

• Degree: Master’s or Doctoral degree received within last 60 months or currently pursuing.
• Discipline: Life, Health, and Medical Sciences – Pharmacology.

Contact

Ashley