Clinical Regulatory Expert for FDA AI Evaluation

Apply clinical regulatory expertise to evaluate FDA-facing evidence packages and develop rigorous information-request scenarios for AI assessment. Role Overview

• Validate clinical data rooms and supporting documents against FDA evidentiary standards and formatting expectations, including intentionally embedded defects designed to assess regulatory judgment.
• Author FDA information requests and model responses, then create prompts, reference outputs, and scoring rubrics to measure an AI agent’s ability to perform comparable work.

• MD, PhD, PharmD, or equivalent qualification.
• At least 5 years of relevant experience, with 10 to 25 years preferred.
• Experience reviewing or responding to FDA information requests involving CMC, patient-level data, investigator qualifications, and biomarker or endpoint evidence.
• Direct FDA review experience is strongly preferred over sponsor-side liaison experience.
• No conflict of interest with a current federal employer.

• Remote hourly engagement.
• Must be located in the United States, Canada, or France.
• Availability of at least 20 to 25 hours per week is required; 30 or more hours per week is preferred.

• $130 to $170 per hour.