Medical Monitoring Director

Enveda

6d•$280,000 - $330,000•Remote

About The Position

Enveda is hiring a Medical Monitoring Director to provide sponsor-physician oversight for its clinical trials. The director will serve as medical monitor on assigned studies, oversee consultant medical monitors on other studies, and build an in-house medical monitoring team as trials move in house. The role reports to the SVP, Clinical Development and works closely with clinical leads, Clinical Operations, Biostatistics, and the in-house Pharmacovigilance team. The director will also own the clinical requirements and release approval for AI tools used in blinded safety monitoring. The role has medical decision-making responsibility for assigned studies and influences medical oversight across a three-program clinical pipeline. The position includes safety oversight of Phase 1 and Phase 2 trials, participation in dose-escalation committees, chairing internal blinded safety reviews, and presenting sponsor updates to independent data monitoring committees where applicable. The director will develop medical monitoring plans and safety rules, perform medical review of study data, set standards for consultant monitors, train investigators and sites, and keep the function inspection-ready. AI tools are limited to blinded data and may flag or draft information; seriousness and causality remain the physician's decisions, while Pharmacovigilance determines expectedness and reportability and controls unblinding. This is a remote, full-time position with a stated salary range of $280,000–$330,000. Enveda describes itself as a clinical-stage, AI-enabled biotech with three oral medicines in clinical development.

Requirements

MD, DO, or equivalent, with completed residency training and clinical practice experience.
At least 5 years of industry medical monitoring or drug safety experience, including hands-on medical monitoring of Phase 1 and Phase 2 studies.
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 interpret adverse event, laboratory, vital sign, and ECG data and make clear medical decisions while protecting the blind and prioritizing participant safety.
Ability to define what AI tools should do for medical monitors, check their output, and identify decisions that tools must not make.
Collaborative, hands-on, patient-first approach.

Nice To Haves

Board certification.
An active medical license.
Experience in inflammatory, immunologic, dermatologic, gastrointestinal, or metabolic disease.

Responsibilities

Serve as sponsor medical monitor on assigned studies, including answering site questions about eligibility and protocols, assessing causality for serious adverse events, and making medical judgments required of the sponsor's physician.
Participate in dose-escalation safety review committees for Phase 1 studies and chair internal blinded safety reviews.
Present sponsor updates in the open session of an independent data monitoring committee when a study has one.
Write medical monitoring plans and own protocol stopping rules, dose-modification rules, and safety monitoring schedules with clinical leads.
Contribute medical content to investigator brochures, safety update reports, and study reports.
Review protocol deviations, MedDRA and WHODrug coding, SAE reconciliation, and data listings before database lock.
Onboard consultant medical monitors, establish the plans and escalation paths they follow, review their decisions, and share the 24-hour medical monitor line.
Define clinical requirements for AI tools used for blinded safety monitoring, including monitor-facing information, flag rules, acceptance criteria, and release sign-off.
Train investigators and sites on safety reporting and eligibility.
Maintain inspection readiness through SOPs and a searchable record of medical decisions.
Define roles for the in-house medical monitoring team and hire and lead the team as approved.