Medical Monitoring Director

Job Summary

As a full-time Medical Monitoring Director working remotely, the successful candidate will oversee clinical trials as a sponsor physician, manage consultant medical monitors, and build an in-house medical monitoring team while collaborating with clinical leads and engineers on AI tools for safety monitoring.

Key responsibilities

• Serve as the medical monitor for clinical studies, addressing eligibility and protocol questions, and making medical judgment calls
• Chair safety review committees for Phase 1 studies and write medical monitoring plans, including stopping and dose-modification rules
• Train investigators and sites on safety reporting and eligibility while ensuring compliance with SOPs and maintaining inspection readiness

Required qualifications

• MD or DO (or equivalent) with completed residency training and clinical practice; board certification and active medical license preferred
• 5+ years of experience in industry medical monitoring or drug safety, particularly with Phase 1 and Phase 2 studies
• Knowledge of ICH E6(R3), E2A and E2F, and US IND safety reporting, along with experience with blinded safety review committees
• Proven ability to make data-driven medical decisions regarding adverse events and participant safety
• Familiarity with AI tools and a collaborative, patient-first approach to clinical trials