Contract Medical Monitor

Phase 1 (Healthy Volunteer) | Small Molecule | I&I

Location: United States (Remote with limited on-call availability)

Time Commitment: ~20 hours/week

Duration: 6 months (initial term, with potential extension)

Overview

A clinical-stage biotechnology company is seeking an experienced Contract Medical Monitor to support a U.S.-based Phase 1 healthy volunteer study for a small molecule investigational therapy in the immunology & inflammation (I&I) space.

This is a hands-on, high-impact role suited for a physician with strong SAD/MAD experience who enjoys working closely with Clinical Operations, Safety, and CRO partners during early clinical development.

Key Responsibilities

Clinical Oversight & Subject Safety

• Provide ongoing medical monitoring oversight for a Phase 1 healthy volunteer study
• Review safety data, including AEs, SAEs, labs, ECGs, and vital signs
• Assess dose escalation decisions and emerging safety signals
• Serve as the primary medical escalation point for clinical safety issues

Protocol & Study Support

• Support protocol review, safety sections, and medical monitoring plans
• Provide medical input into inclusion/exclusion criteria and stopping rules
• Participate in Safety Review Committee (SRC) and dose-escalation meetings

Cross-Functional Collaboration

• Partner closely with Clinical Operations, Pharmacovigilance, and CRO teams
• Support site questions related to subject eligibility, safety events, and protocol interpretation
• Contribute to investigator communications and training as needed

Strategic Input (Preferred)

• Provide medical perspective on early clinical development strategy
• Offer input into clinical development plans and transition from Phase 1 to later-stage studies (as applicable)

Required Qualifications

• MD or DO (U.S.-licensed or equivalent)
• Prior experience as a Medical Monitor for Phase 1 studies, preferably healthy volunteer trials
• Strong background in small molecule drug development
• Demonstrated experience supporting SAD/MAD study designs
• Familiarity with I&I therapeutic areas
• Experience working with U.S.-based CROs and clinical sites
• Ability to commit ~20 hours per week for the duration of the engagement

Preferred Experience

• Prior involvement in early clinical development planning
• Experience supporting transition from Phase 1 into Phase 2
• Comfort working in lean, fast-moving biotech environments
• Previous consulting or fractional medical monitor roles