Director Medical Monitor

Job Title: Director Medical Monitor, Location: Parsippany, NJ, Type: Direct Hire, Contractor Work Model: Hybrid – onsite. Responsibilities Provide medical oversight for assigned clinical studies from study start-up through closeout. Participate in protocol development, protocol amendments, informed consent review, and clinical study report preparation. Serve as the primary medical contact for investigators and study sites regarding protocol-related medical questions, including subject eligibility and enrollment guidance. Conduct ongoing medical review of subject safety data, eligibility determinations, protocol deviations, and emerging risk signals to ensure patient safety and scientific integrity. Review and interpret clinical data and trends, including safety data, laboratory values, adverse events, and protocol deviations. Support dose escalation decisions and safety review meetings, where applicable. Provide medical training and support site initiation visits, investigator meetings, monitoring activities, and data review committees (e.g., DSMB) as needed. Collaborate with Pharmacovigilance teams on safety reporting requirements, safety management plans and risk mitigation strategies, and elevate safety concerns when needed. Collaborate with Clinical Operations to ensure studies are conducted timely and in compliance with GCP, SOPs, and regulatory guidelines. Support Regulatory Affairs in regulatory submissions and responses to regulatory agencies. Contribute to audit and inspection readiness activities. Requirements MD or DO required; Board eligible/certified preferred. Infectious Diseases expertise preferred. 5-8 years clinical drug development experience. Experience in the design, conduct and analysis of Phase 1-4 studies; experience in global clinical trials and with CROs preferred. Strong understanding of clinical research, ICH-GCP, FDA, EMA, and other applicable regulatory requirements. Strong analytical and problem-solving abilities with the ability to interpret clinical and safety data and apply sound medical judgment. Excellent communication and presentation skills. Leadership and cross-functional collaboration skills in a fast-paced environment. Experience reviewing clinical and safety data listings, narratives, and aggregate analyses. Additional clinical research training or certification or regulatory experience is a plus. Willingness to travel up to 25% for investigator meetings, site visits, and clinical study activities as needed. Benefits We offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. Equal Opportunity Employer System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #J-18808-Ljbffr