Medical Monitoring Director

Let’s build the future of medicine - together. Remote | Full-time | $260,000 - $320,000 YOUR ROLE As a Medical Monitoring Director at Enveda, you'll be a sponsor physician on our clinical trials: medical monitor on the studies you take on, the physician who oversees the consultant medical monitors on the rest, and, as trials move in house, the person who builds the in-house medical monitoring team. You'll report to the SVP, Clinical Development, work day to day with the clinical leads, Clinical Operations, Biostatistics, and our in-house Pharmacovigilance team, and be the clinical owner of the AI tools our engineers build for blinded safety monitoring. The medical decisions on your studies are yours, and the consultant monitors work to plans you sign. This is a high impact opportunity where you'll influence the medical oversight of a three-program clinical pipeline while collaborating with some of the brightest minds in the industry. WHAT YOU'LL DO Serve as the sponsor's medical monitor on your studies, blinded where the study is blinded: eligibility and protocol questions from sites, the sponsor's causality assessment on every serious adverse event, and the medical judgment calls the protocol asks of the sponsor's physician Sit on the dose-escalation safety review committees for our Phase 1 studies and chair the internal blinded safety review for each study, presenting the sponsor's update in the open session of the independent data monitoring committee where a study has one Write the medical monitoring plans, own the protocol's stopping rules, dose-modification rules, and safety monitoring schedule with each clinical lead, and contribute the medical content of investigator's brochures, safety update reports, and study reports Do the medical review the data needs: protocol deviations, MedDRA and WHODrug coding, SAE reconciliation, and the listings before database lock Set the standard for the consultant medical monitors: onboard them, define the plans and escalation paths they work to, review their decisions, and share the 24-hour medical monitor line with them Be the clinical owner of the AI tools Enveda's engineers build for blinded safety monitoring: define what a medical monitor needs to see, set the flag rules, write the acceptance criteria, and sign off on each release. The tools work on blinded data only and flag and draft for you. Seriousness and causality are assessed by you, expectedness and reportability by Pharmacovigilance, which also holds the unblinding, and none of them by a tool Train investigators and sites on safety reporting and eligibility, and keep the function inspection-ready with SOPs and a searchable record of medical decisions Build the in-house medical monitoring team as trials move in house: define the roles, then hire and lead as the team is approved WHAT WE'RE LOOKING FOR 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 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, and of the early-phase safety assessments an oral small molecule needs (liver safety, QT, stopping rules) Experience overseeing CRO or consultant medical monitors and pharmacovigilance vendors, and with blinded safety review committees and independent data monitoring committees Data-driven judgment: you turn adverse event, laboratory, vital sign, and ECG data into clear decisions, protect the blind, and know when a participant's safety comes first AI-native or AI-curious: you can say what a tool should do for a medical monitor, how you would check its output, and what it must never decide Ego-lite, hands-on, and patient-first: collaborative, direct, no task too big or small, and never losing sight of who the trial is for