Regulatory Dose-Finding Analyst - Targeted Oncology

Oak Ridge Institute for Science and Education; White Oak (MD); On-site; USD 27,000 - 45,000; Full time

Job summary

Oak Ridge Institute for Science and Education (ORISE) offers a full-time research opportunity with FDA-CDER in White Oak, MD. The project focuses on collecting and analyzing dosage selection strategies for oncology drugs, including RP2D, MTD/MAD, and DLTs.

You will engage with leadership, present findings, and contribute to manuscripts. Eligibility requires a master's or doctoral degree in a relevant field.

Qualifications

• The qualified candidate should be currently pursuing or have received a master's or doctoral degree in the one of the relevant fields.

Responsibilities

• Collect and analyze dosage optimization strategies from recent NDAs, BLAs, and INDs for targeted oncology drugs.
• Identify patterns and trends in dose-finding study designs, RP2D, MTD/MAD, and exposure‑response relationships.
• Discuss findings with FDA clinical pharmacology leadership and team leads to inform potential regulatory guidance.
• Present results to DCP or clinical pharmacology audiences and contribute to a manuscript.

Education

Master's Degree or Doctoral Degree

Job description

Oak Ridge Institute for Science and Education (ORISE) offers a full-time research opportunity with FDA-CDER in White Oak, MD. The project focuses on collecting and analyzing dosage selection strategies for oncology drugs, including RP2D, MTD/MAD, and DLTs.

You will engage with leadership, present findings, and contribute to manuscripts. Eligibility requires a master's or doctoral degree in a relevant field.