Senior Director, Clinical System Operations

Job description

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. Senior Director – Clinical System Operations What you will do: In this vital role, the Senior Director – Clinical Systems Operations will be responsible for ensuring the reliability, availability, performance, compliance, and operational excellence of Amgen's global Clinical Systems ecosystem. This leader will establish and lead an integrated Clinical Systems Operations function accountable for end-to-end service management, platform health, release governance, incident management, audit readiness, business continuity, operational intelligence, and technology partner performance across the clinical development landscape. Serving as a strategic business technology leader, this role will partner closely with GDO, DTI, SaaS providers, and strategic operational partners to ensure clinical systems remain secure, compliant, resilient, and continuously available to support study start-up, study conduct, clinical data acquisition, monitoring, reporting, and submission activities across the global development portfolio. The Senior Director – Clinical Systems Operations will be accountable for defining and executing an operational strategy that advances GDO's Digital and Differentiated Delivery ambitions while establishing a modern service management framework built on service performance, proactive monitoring, integrated release management, business continuity planning, vendor accountability, and measurable service outcomes. This role ensures that Clinical Systems continue to operate as trusted enterprise platforms capable of supporting current business demands while scaling for future growth, innovation, AI-enabled capabilities, and evolving regulatory expectations. Strategic Leadership Define and Lead the Clinical Systems Operations Strategy: Establish and execute Amgen's enterprise Clinical Systems Operations strategy, creating a scalable operational framework that ensures high availability, compliance, resilience, performance, and operational maturity across the Clinical Systems landscape. Establish Operational Excellence and Service Reliability: Drive a culture of business resilience by defining enterprise standards, governance models, service management practices, and reliability strategies that ensure Clinical Systems remain available, performant, secure, and audit-ready at all times. Operational governance and Performance: Establish enterprise service governance, operational performance frameworks, and vendor accountability models including SLAs, SLOs, KPIs, operational contracts, capacity planning, and financial oversight across the Clinical Systems ecosystem. Advance Operational Intelligence and Platform Observability: Partner with DTI, SaaS providers, and technology partners to establish modern monitoring, observability, automation, and operational analytics capabilities that enable proactive identification and resolution of service risks before they impact business operations. Drive Vendor, Partner, and SaaS Operational Accountability: Define operational contracts, service expectations, accountability models, and performance measurement frameworks with DTI, strategic service providers, and SaaS vendors to ensure consistent delivery of agreed service levels and business outcomes. Build Enterprise Resilience and Business Continuity Readiness: Lead the strategy for business continuity, disaster recovery, contingency planning, operational recovery testing, and resilience across the Clinical Systems ecosystem to ensure uninterrupted support for critical clinical development activities. Execution and Delivery Leadership Deliver Reliable, Secure, and Audit-Ready Clinical Systems: Provide end-to-end operational accountability for the Clinical Systems landscape, ensuring systems remain compliant, validated, secure, highly available, and inspection-ready while enabling uninterrupted business operations. Lead Integrated Incident, Problem, and Service Performance Management: Oversee enterprise incident management, root cause analysis, problem resolution, service recovery, and continuous improvement activities while ensuring service disruptions are minimized and operational commitments are consistently achieved. Execute Integrated Release and Platform Enhancement Delivery: Govern enterprise release management processes, platform upgrades, SaaS releases, system enhancements, and operational change activities to ensure successful delivery with minimal business disruption and maximum value realization. Measure and Improve Operational Health and Business Outcomes: Define, monitor, and report operational KPIs, SLAs, SLOs, compliance metrics, availability targets, incident trends, recovery performance, vendor effectiveness, and platform health indicators to continuously improve service performance and user experience Functional Management Build and lead a high-performing organization focused on execution and delivery of the GDO Strategic Business Plan and associated enterprise transformation commitments. Lead, mentor, and develop a global team while fostering a culture of accountability, agility, collaboration, innovation, and continuous improvement. Develop organizational capabilities, operating models, and skillsets required to support evolving business, technology, and portfolio needs. Partner closely with GDO leadership and enterprise stakeholders to align transformation priorities, resource needs, and execution plans. External Representation and internal stakeholder partnerships Collaborate across the external life sciences landscape, Tech and SaaS providers, AI&D, DTI and GDO functions to ensure strategic initiatives, transformation activities, and operational priorities remain aligned and effectively executed. Support evaluation and integration activities related to new technologies, external partnerships, and organizational transformation opportunities, including M&A activities as applicable. Maintain external awareness of industry trends, competitive capabilities, and innovation opportunities that may enhance operational quality, efficiency, speed, and scalability. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an experienced leader with the following qualifications. Basic Qualifications: Master’s with 15+ years of clinical systems Operations and Service Management OR Bachelor’s with 18+ years of clinical systems Operations and Service Management AND 5+ years of people leadership experience directly managing teams, programmes, projects, or enterprise resources. Preferred Qualifications: 15+ years of experience leading enterprise clinical technology operations, platform lifecycle management, service delivery, and operational excellence within the biopharmaceutical industry. Demonstrated success leading large-scale operational transformation initiatives, including technology modernization, process optimization, service management maturity, organizational change, and business capability development. Experience implementing and operating enterprise monitoring, automation, observability, operational analytics, and AI-enabled service management capabilities within regulated environments. Proven experience establishing and governing global technology operations, service delivery organizations, vendor partnerships, and operational performance frameworks across complex enterprise environments. Deep understanding of GxP systems operations, inspection readiness, SaaS operating models, business continuity planning, disaster recovery, and regulatory expectations within clinical development environments. Technical knowledge of modern Clinical Systems platforms, operational monitoring capabilities, digital technologies, automation, AI-enabled operations, and enterprise integration frameworks supporting clinical development. Core Competencies: Enterprise leadership across clinical systems and technology operations with deep expertise in service management, governance, and operational excellence. Deep understanding of Clinical Systems platforms including CTMS, EDC, DQS/CDR, Digital Protocol, RBQM, integration frameworks, and clinical data flows. Expertise leading global Clinical Systems operations across complex multi-platform ecosystems, including SaaS environments, integrations, service resilience, monitoring, observability, and vendor governance. Experience defining and operationalising compliant, secure, validated, and inspection-ready GxP technology landscapes. Strategic thinking with the ability to drive business performance through operational excellence, service reliability, technology optimization, and continuous improvement. They will also embody the Amgen leadership attributes which are: Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. .