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, review informed consent materials, contribute to clinical study report preparation, and serve as the primary medical point of contact for investigators and study sites on protocol-related medical questions, including subject eligibility and enrollment guidance.
The Director Medical Monitor will conduct ongoing review of subject safety data, eligibility determinations, protocol deviations, and emerging risk signals to help ensure patient safety and scientific integrity. Responsibilities include interpreting clinical data and trends (including safety data, laboratory values, and adverse events), supporting dose escalation decisions and safety review meetings where applicable, and providing medical training and support for site initiation visits, investigator meetings, monitoring activities, and data review committees (such as DSMB) as needed.
Key collaboration areas include working with Pharmacovigilance on safety reporting requirements, safety management plans, and risk mitigation strategies, as well as partnering with Clinical Operations to support study execution in compliance with GCP, SOPs, and regulatory guidelines. The role also supports Regulatory Affairs for regulatory submissions and responses, contributes to audit and inspection readiness activities, and is expected to travel up to 25% for investigator meetings, site visits, and clinical study activities as needed. Required qualifications include an MD or DO (board eligible/certified preferred), strong knowledge of clinical research and ICH-GCP and applicable regulatory requirements (including FDA and EMA), analytical and problem-solving skills to interpret clinical and safety data, excellent communication and presentation skills, and leadership and cross-functional collaboration experience; infectious diseases expertise and experience with Phase 1–4 global trials and CROs are preferred.