The Director, Medical Monitoring, is a key role responsible for ensuring appropriate medical oversight in conducting the study protocol including the integrity of assigned clinical studies in accordance with Good Clinical Practice (GCP). This role operates as a key contributor, ensuring high quality medical review and timely assessments supporting medical decision support and program execution
This role is based in our Lexington, MA office and requires employees to be onsite five days per week.
Responsibilities (including, but not limited to):
- Provide ongoing medical monitoring oversight for assigned clinical trials, including real-time review of safety data, adverse events, data listings, protocol deviations, eligibility, and laboratory findings to ensure data quality
- Serve as a medical point of contact for investigators and sites on eligibility, protocol interpretation, and participant management questions, including providing medical support for routine medical inquiries from internal and external study teams and sites
- Engage with investigators, advisors, and external experts to support trial execution and clinical oversight
- In collaboration with Global Medical Safety, review and assess adverse events and serious adverse events, including causality assessment, and support safety signal detection in partnership with Pharmacovigilance
- Provide clinical input into protocol design, amendments, informed consent forms, and other study-related documents
- Review and interpret clinical and safety data to inform potential protocol adjustments and trial-level decisions
- Develop and maintain medical monitoring plans and safety review processes for assigned studies in collaboration with Global Medical Safety
- Partner closely with Clinical Operations and CRO on trial conduct, site management, and medical monitoring activities, including leading and supporting discussions with Data Monitoring Committees (DMC)
- Partner with Biometrics and Regulatory Affairs to ensure clinical data support statistical and regulatory requirements
- Collaborate closely with cross-functional team, including Program Management, Medical Safety/Pharmacovigilance, Regulatory Affairs, Biometrics, Medical Affairs, and CMC teams
- Contribute to safety reports, DSURs, and responses to health authority questions
- Provide clinical input into briefing documents, responses to regulatory questions, and clinical components of submissions
- Document all medical monitoring activities and communications related to assigned studies in TMF
- Support preparation for and participate as applicable in site initiation visits and investigator meetings
Standout Skills for Impact:- Clear and credible communication skills with investigators, cross-functional teams, senior management
- Ability to anticipate enrollment and endpoint challenges before they arise
- Proactive approach in identifying trends early and defining mitigation strategies rather than reacting to problems
- Personable ability to build constructive relationships with investigators and study team
- Ability to handle difficult conversations around protocol deviations, eligibility decisions, and safety events diplomatically
Qualifications and Experience: - 5+ years of clinical development and/or medical monitoring experience in biotechnology and/or pharmaceutical organizations, with an MD degree; prior experience as a practicing physician is preferred
- Hands-on medical monitoring experience in Phase 2-3 clinical trials
- Experience supporting programs through key clinical trial milestones (e.g., study start-up, interim analyses, pivotal study conduct)
- Strong ability to integrate clinical, safety, and scientific data into sound clinical and risk-benefit decisions
- Solid understanding of global clinical development, GCP, and patient safety requirements
- Familiarity with regulatory submissions (e.g., NDA, BLA, MAA) and support of health authority interactions
- Comfortable operating as an individual contributor in a lean, dynamic environment
- Models transparency, collaboration, and patient-centric decision-making
- Ability to travel domestically and internationally up to 20% for purposes such as site visits and investigator meetings
Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
Pay Range
$286,000-$316,000 USD
