The client is seeking a Director Medical Monitor to provide medical oversight for assigned clinical studies from start-up through closeout. In this role, you will participate in protocol development and amendments, support informed consent review, and contribute to clinical study report preparation, helping ensure scientific integrity and subject safety throughout the study lifecycle.
You will serve as the primary medical contact for investigators and study sites for protocol-related medical questions, including subject eligibility and enrollment guidance. Responsibilities also include ongoing medical review of subject safety data, eligibility determinations, protocol deviations, and emerging risk signals; review and interpretation of clinical data trends such as safety data, laboratory values, and adverse events; and support for dose escalation decisions and safety review meetings where applicable.
The Director Medical Monitor will provide medical training and support site initiation visits, investigator meetings, monitoring activities, and data review committees (e.g., DSMB) as needed. You will collaborate with Pharmacovigilance on safety reporting and risk mitigation strategies, escalate safety concerns when required, and work with Clinical Operations to help ensure studies are conducted in compliance with GCP, SOPs, and regulatory guidance; you will also support Regulatory Affairs for submissions and responses and contribute to audit and inspection readiness. The role typically requires an MD or DO (board eligible/certified preferred) with clinical drug development experience, strong knowledge of clinical research and ICH-GCP and applicable regulatory requirements, strong analytical and communication skills, and demonstrated leadership and cross-functional collaboration; Infectious Diseases expertise, infectious data review experience, and additional clinical research or regulatory training may be preferred. Travel up to 25% may be expected for investigator meetings, site visits, and related clinical study activities.