Medical Monitoring Director

Enveda

. 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 .

Posted 11/5/2026full-timeRemote • United StatesLead💰 $280,000 - $330,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical monitoring and drug safety, with a strong focus on Phase 1 and Phase 2 studies, including safety assessments and protocol adherence. Capable of leading teams, training investigators, and ensuring compliance with regulatory standards.

Highest-signal resume keywords

MD Or DOMedical MonitoringDrug SafetyICH E6(R3)Phase 1 And Phase 2 Studies

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Causality AssessmentProtocol Deviation ReviewMedDRA CodingSAE ReconciliationSafety Monitoring PlansDose-Modification RulesSafety ReportingAdverse Event AnalysisEarly-Phase Safety AssessmentsClinical Requirements Sign-Off

Soft Skills

Collaborative ApproachDirect CommunicationHands-On LeadershipPatient-First Mindset

Tools & Technologies

AI ToolsBlinded Safety Review CommitteesIndependent Data Monitoring Committees

Certifications & Qualifications

Board CertificationActive Medical License

Industry Keywords

PharmacovigilanceInflammatory DiseaseImmunologic DiseaseDermatologic DiseaseGastrointestinal DiseaseMetabolic DiseaseUS IND Safety Reporting

Tech Stack

Tools & technologies

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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