Lead Medical Data Reviewer

<h2><b>Career Category</b></h2>Clinical Development<h2></h2><h2><b>Job Description</b></h2><p>In this vital role, the Senior Manager, Medical Information (Medical Data Reviewer Lead) is accountable for the strategic and operational leadership of the Medical Data Reviewer (MDR) function across multiple Therapeutic Areas (TAs). This role ensures harmonized MDR practices across the portfolio while enabling TA-specific nuances and risk-based decision-making. The MDR Lead partners closely with cross functional teams to deliver high-quality, decision-ready clinical data in support of Amgen’s development strategy. </p><ul><li><p>Provide strategic and operational leadership of the Medical Data Reviewer (MDR) function across assigned Therapeutic Areas, ensuring alignment with enterprise clinical development and data management strategies </p></li></ul><ul><li><p>Partner with Therapeutic Area leadership, Clinical Operations, Clinical Data Management, Global Safety, and Data &amp; Digital teams to proactively manage risks, dependencies, and resourcing needs </p></li></ul><ul><li><p>Drive standardization of MDR processes, quality frameworks, analytics, and tools while enabling appropriate TA-specific flexibility </p></li></ul><ul><li><p>Oversee overall MDR workload planning, capacity management, and prioritization to support study timelines, data quality, and inspection readiness </p></li></ul><ul><li><p>Lead, mentor, and develop Senior MDRs, building leadership capability, strong judgment, and consistent performance across the MDR organization </p></li></ul><ul><li><p>Identify and resolve systemic, cross-TA issues impacting data quality, review efficiency, or portfolio delivery </p></li></ul><ul><li><p>Lead continuous improvement initiatives, including automation, advanced analytics, and new ways of working to enhance MDR effectiveness and scalability </p></li></ul><ul><li><p>Represent the MDR function in governance forums, portfolio discussions, and cross-functional leadership meetings </p></li></ul><p></p><p><b>What we expect of you</b> </p><p>We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. </p><p></p><p><b>Basic Qualifications:</b> </p><p>Doctorate degree and 12&#43; years of life sciences/healthcare experience </p><p>OR </p><p>Master’s degree and 12&#43; years of life sciences/healthcare experience </p><p></p><p><b>Preferred Qualifications:</b> </p><ul><li><p>MD or equivalent </p></li></ul><ul><li><p>9&#43; years of experience in life sciences or a medically related field, including significant experience in medical monitoring and/or clinical data review </p></li></ul><ul><li><p>Prior people management experience with direct reports </p></li></ul><ul><li><p>Demonstrated strategic leadership of a clinical data review or medical monitoring function </p></li></ul><ul><li><p>Experience leading clinical trial process improvement and data quality optimization initiatives </p></li></ul><ul><li><p>Strong communication and presentation skills (written and oral) </p></li></ul><ul><li><p>Deep understanding of operational aspects of clinical data review </p></li></ul><ul><li><p>Advanced proficiency with clinical data analysis tools (e.g., Spotfire or equivalent) </p></li></ul><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.