Senior Director, Medical Review

Senior Director, Medical Review Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.  Job Responsibilities Patient Profile Review • Perform physician review and medical interpretation of patient profiles in accordance with study procedures, project plans, and timelines. • Document findings and identify issues requiring clarification, follow-up, or escalation. Medical Validation and Triage • Validate medically significant findings identified through Medical Scientist-led data review without duplicating the primary review. • Assess the medical relevance of trends, potential signals, protocol-related concerns, and subjectlevel findings; determine appropriate disposition and escalation. • Provide medical clarification and guidance to Medical Scientists regarding review findings. Medical Review Reporting and Escalation • Prepare concise medical data review summaries for Regional Medical Directors highlighting significant findings, emerging trends, potential subject safety concerns, outstanding questions, and items requiring action. • Communicate and escalate validated findings with sufficient clinical context and medical rationale to support Regional Medical Director site and sponsor guidance, Medical Director assessment, and study oversight. Quality, Collaboration, and Compliance