Director, RBQM Platforms & Technology

Career Category Clinical Development 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, obesity and obesity-related conditions. 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 – Risk-Based Quality Management (RBQM) Platforms & Technology What you will do: This role serves as the business product owner for Amgen's RBQM ecosystem and is responsible for defining and executing the technology, analytics, and operational intelligence strategy that enables proactive identification, assessment, monitoring, and mitigation of study risks. This role is responsible for defining and executing the RBQM technology strategy that enables proactive identification, assessment, monitoring, and mitigation of study risks while driving quality, efficiency, and speed in study execution. The position serves as the business technology leader connecting Study Start-Up (SSU), Site & Study Operations (SSO), Data Management, and broader Global Development Operations through integrated risk management, central monitoring, operational analytics, and AI-enabled insights. As a strategic enabler of GDO's ACT FAST, TWFS, and D2 transformation priorities, the Director will establish a scalable RBQM ecosystem that transforms fragmented operational and clinical data into actionable intelligence, enabling earlier risk detection, targeted interventions, accelerated study execution, improved site performance, and enhanced trial quality. Strategic Leadership Own the Enterprise RBQM Vision and Strategy: Define and lead Amgen's enterprise strategy for Risk-Based Quality Management, establishing a future-ready framework that leverages central monitoring, analytics, automation, and AI-enabled insights to improve study quality, execution, and patient outcomes. Drive Risk-Based Clinical Trial Transformation: Establish the operating model, governance framework, standards, and business processes required to transition from traditional oversight approaches to proactive, data-driven risk management across the clinical trial lifecycle. Drive RBQM Platform Innovation and Capability Expansion: Lead evolution of RBQM platforms, data assets, analytics capabilities, and risk intelligence solutions to support future business needs and regulatory expectations. Advance Operational Intelligence and Predictive Risk Management: Champion the use of advanced analytics, AI, central monitoring, and predictive risk indicators to enable earlier identification of study, site, patient, data quality, and operational risks across the portfolio. Drive Enterprise Alignment Across GDO Functions: Partner with SSU, SSO, Data Management, Biostatistics, Study Teams, Clinical Systems, AI&D, DTI, and business leadership to align RBQM capabilities with ACT FAST, TWFS, D2, and broader enterprise transformation objectives. Influence Industry Innovation and Regulatory Readiness: Represent Amgen in industry working groups, technology partnerships, and external forums to shape the future of RBQM, central monitoring, digital trial