Clinical Medicine
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International Recruiting LLC
US
Summary
The medical monitor will oversee subject safety, clinical data quality, and protocol compliance for US clinical programs. They will provide medical guidance to cross-functional teams and support regulatory activities including FDA submissions and safety reporting.
Job Description
This position will serve as the sponsor-side medical monitor and clinical development lead for Zenitar’s US clinical programs. The role is responsible for subject safety, medical data quality, eligibility review, safety signal assessment, protocol compliance, medical communication with investigators, and clinical support for late-stage development and pre-launch activities.
Key Responsibilities
• Serve as the sponsor-side medical monitor for US and global clinical studies.
• Review subject eligibility, protocol deviations, safety events, laboratory abnormalities, and emerging medical risks.
• Conduct ongoing review of clinical and safety data and support identification, assessment, and escalation of potential safety signals.
• Provide medical guidance to investigators, CRO medical teams, clinical operations, pharmacovigilance, and data management.
• Support SAE review, safety narratives, aggregate safety assessments, unblinding procedures, and FDA safety reporting.
• Participate in protocol development, investigator meetings, site training, medical review meetings, and data review committees.
• Provide clinical support for late-stage and pre-launch activities, including database lock, topline data review, regulatory submissions, health authority responses, investigator communications, and publication planning.
• Draft and critically review clinical and regulatory documents, including protocols, investigator’s brochures, clinical study reports, safety narratives, briefing packages, regulatory responses, manuscripts, abstracts, and presentations.
• Review SAPs, TFLs, clinical listings, and data outputs from a medical and scientific perspective.
• Work closely with clinical operations and CRO teams to ensure trial quality, timely issue resolution, and consistent medical oversight.
Key Qualifications
• MD, DO, or equivalent advanced clinical medical degree.
• US clinical training, US medical experience, and/or USMLE background is preferred.
• Approximately 5-8 years of clinical development or medical monitoring experience, preferably within a sponsor organization.
• Experience supporting Phase 2/3 and pre-approval clinical programs is required.
• Strong experience in hematology/oncology; experience with MF, MPN, or JAK inhibitor programs is highly preferred.
• Familiarity with FDA safety reporting requirements, GCP, medical monitoring standards, and clinical trial governance.
• Demonstrated medical writing and document review capabilities across clinical and regulatory deliverables.
• Strong ability to interpret patient-level clinical data and communicate medical conclusions clearly to investigators and cross-functional teams.
• Comfortable working independently and hands-on within a biotech company.
