The client is seeking a Director, Medical Monitor to provide medical oversight for assigned clinical studies from start-up through closeout. This role will support protocol development and amendments, informed consent review, and preparation of clinical study reports. The Director, Medical Monitor will serve as the primary medical contact for investigators and study sites for protocol-related questions, including subject eligibility and enrollment guidance.
Key responsibilities include conducting ongoing medical review of subject safety data, eligibility determinations, protocol deviations, and emerging risk signals to help ensure patient safety and scientific integrity. The role will review and interpret clinical data and trends, including safety data, laboratory values, adverse events, and protocol deviations, and will support dose escalation decisions and safety review meetings where applicable. The Director, Medical Monitor will also provide medical training and support for site initiation visits, investigator meetings, monitoring activities, and data review committees as needed.
The Director, Medical Monitor will collaborate with pharmacovigilance teams on safety reporting requirements, safety management plans, and risk mitigation strategies, escalating safety concerns when needed. The role will work with clinical operations to help ensure studies are conducted in compliance with GCP, SOPs, and regulatory guidance, and will partner with regulatory affairs on regulatory submissions and responses to regulatory agencies. Required qualifications include an MD or DO with board eligible/certified preference, infectious diseases expertise preferred, and clinical drug development experience with Phase 1–4 study design, conduct, and analysis, along with strong understanding of ICH-GCP and applicable regulatory requirements; additional clinical research training and willingness to travel up to 25% for study activities are also expected.