Medical Monitoring Director

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the medical monitor for the sponsor on assigned studies, addressing eligibility and protocol inquiries, evaluating causality for serious adverse events, and making medical decisions as the sponsor's physician.

• Engage in dose-escalation safety review committees for Phase 1 studies.

• Lead internal blinded safety reviews and present updates to independent data monitoring committees on behalf of the sponsor.

• Develop medical monitoring plans and establish stopping rules, dose-modification criteria, and safety monitoring schedules.

• Provide medical content for investigator brochures, safety update reports, and study documentation.

• Assess protocol deviations, conduct MedDRA and WHODrug coding, reconcile serious adverse events, and review listings prior to database locking.

• Set standards for, onboard, and evaluate consultant medical monitors.

• Manage clinical requirements and approve AI tools used in blinded safety monitoring.

• Educate investigators and sites on safety reporting and eligibility criteria.

• Ensure inspection readiness with established SOPs and accessible medical-decision records.

• Recruit, build, and lead the in-house medical monitoring team as trials transition in-house.

⛳️ Requirements

• MD or DO (or equivalent) with completed residency training and clinical practice experience.

• Board certification and an active medical license are preferred.

• At least 5 years of experience in industry medical monitoring or drug safety, including direct medical monitoring of Phase 1 and Phase 2 studies.

• Preferably possesses experience in inflammatory, immunologic, dermatologic, gastrointestinal, or metabolic diseases.

• Proficient understanding of ICH E6(R3), E2A and E2F, US IND safety reporting, MedDRA coding review, and SAE reconciliation.

• Familiarity with early-phase safety evaluations for oral small molecules, including liver safety, QT interval, and stopping rules.

• Experience overseeing CRO or consultant medical monitors along with pharmacovigilance vendors.

• Background working with blinded safety review committees and independent data monitoring committees.

• Capability to translate adverse event, laboratory, vital sign, and ECG data into precise decisions while maintaining the integrity of the blind.

• AI-native or AI-curious; capable of defining tool requirements, assessing outputs, and identifying decisions that should not be made by tools.

• A collaborative, straightforward, hands-on, and patient-first mindset.

🏝️ Benefits

• Medical, dental, and vision coverage at 90%.

• 401(k) plan with company matching.

• Flexible paid time off (PTO).

• Company-wide weeklong recharge break.

• Adoption assistance.