Medical Monitoring Director

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $280k - $330k / year

⏰ Full Time

🔴 Lead

🧪 Clinical Research

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Enveda

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2019

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 $150M Series D - Enveda Biosciences on 2025-09

Healthcare • Consulting • Manufacturing

Enveda is a biotechnology company that leverages a proprietary platform to decode and translate nature’s chemical diversity for accelerated small-molecule drug discovery. By rapidly purifying, identifying, and characterizing molecules from complex natural sources, Enveda aims to put vast, evolutionarily derived chemical space into the hands of drug hunters to discover medicines faster and expand the pipeline of therapeutics.

📋 Description

• Serve as the sponsor's medical monitor on assigned studies, including eligibility and protocol questions, causality assessments for serious adverse events, and sponsor physician medical decisions • Participate in dose-escalation safety review committees for Phase 1 studies • Chair internal blinded safety reviews and present sponsor updates to independent data monitoring committees • Write medical monitoring plans and own stopping rules, dose-modification rules, and safety monitoring schedules • Contribute medical content to investigator brochures, safety update reports, and study reports • Review protocol deviations, MedDRA and WHODrug coding, SAE reconciliation, and listings before database lock • Set standards for, onboard, and review consultant medical monitors • Own clinical requirements and release sign-off for AI tools used in blinded safety monitoring • Train investigators and sites on safety reporting and eligibility • Maintain inspection readiness with SOPs and searchable medical-decision records • Build, hire, and lead the in-house medical monitoring team as trials move in house

🎯 Requirements

• MD or DO (or equivalent) who has completed residency training and practiced clinically • Board certification and an active medical license are preferred • 5 or more years in industry medical monitoring or drug safety, including hands-on medical monitoring of Phase 1 and Phase 2 studies • Ideally experience in inflammatory, immunologic, dermatologic, gastrointestinal, or metabolic disease • Working knowledge of ICH E6(R3), E2A and E2F, US IND safety reporting, MedDRA coding review, and SAE reconciliation • Knowledge of early-phase safety assessments for oral small molecules, including liver safety, QT, and stopping rules • Experience overseeing CRO or consultant medical monitors and pharmacovigilance vendors • Experience with blinded safety review committees and independent data monitoring committees • Ability to turn adverse event, laboratory, vital sign, and ECG data into clear decisions while protecting the blind • AI-native or AI-curious; able to define tool requirements, evaluate outputs, and identify decisions tools must not make • Collaborative, direct, hands-on, patient-first approach

🏖️ Benefits

• Medical, dental, and vision covered at 90% • 401(k) with company match • Flexible PTO • Company-wide weeklong recharge break • Adoption assistance

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