Director - Medical Data Review and Clinical Data Strategy

Director Medical Data Review Career Category Clinical Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Director Medical Data Review What you will do Let’s do this. Let’s change the world. In this vital role, the Director of Medical Data Review is accountable to build and scale the enterprise-wide strategy for medical data review, quality, and risk management across all Therapeutic Areas and development phases. This role will define and evolve the future-state operating model for MDR, including automation, AI augmentation, and talent strategy driving end-to-end integration across Clinical Operations, Data Management, Safety, Biostatistics, and Medical. This role will translate corporate R&D strategy into scalable, data-driven review capabilities. What we expect of you Define and execute the enterprise-wide vision, strategy, and multi-year roadmap for Medical Data Review (MDR), including operating model, technology enablement, workforce capabilities, and organizational transformation. Lead enterprise transformation initiatives that advance risk-based and technology-enabled clinical oversight, including AI-assisted review, automation, RBQM integration, integrated data review, and predictive risk management. Establish and govern enterprise standards, KPIs, quality benchmarks, and risk thresholds to ensure consistent, high-quality medical data review across the clinical development portfolio. Partner with senior leaders across Therapeutic Areas, Clinical Operations, Data Management, Safety, and Digital functions to drive strategic alignment and resolve enterprise-level trade-offs involving quality, timelines, cost, and risk. Establish and lead governance frameworks that provide oversight of clinical data review strategy, quality performance, risk management, and continuous improvement across the organization. Provide strategic leadership for the global MDR organization, including organizational design, resource planning, capability development, and scalable operating models that support diverse clinical programs. Drive operational excellence and trial delivery predictability through proactive performance management, data-driven decision-making, and standardized yet flexible review frameworks. Evaluate emerging industry trends and translate innovations into practical enterprise capabilities that improve quality, efficiency, and risk management. Own the enterprise inspection readiness strategy for clinical data quality, ensuring robust review traceability, regulatory compliance, proactive risk mitigation, and executive-level issue escalation. Champion innovation through the adoption and scaling of advanced analytics, AI/ML-enabled capabilities, predictive risk modeling, and integrated review technologies that transform insights into business outcomes. Build a future-ready MDR organization by defining critical capabilities, strengthening leadership succession, and fostering a culture of decision ownership, risk-based thinking, and predictive oversight. 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. Minimum Requirement: Master/ Doctorate/ MD with ~ 18 years of Industrial experience. 9+ years of experience in life sciences or a medically related field, including significant experience in medical monitoring and/or clinical data review Prior people management experience with direct reports Demonstrated strategic leadership of a clinical data review or medical monitoring function Experience leading clinical trial process improvement and data quality optimization initiatives Strong communication and presentation skills (written and oral) Deep understanding of operational aspects of clinical data review Advanced proficiency with clinical data analysis tools (e.g., Spotfire or equivalent) . Experience Level Executive Level