Senior Director, Integration and Digital Data Flows

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 – Integrated Transformation and Data Flow What you will do: In this vital role as Senior Director – Integration and Digital Data Flow, you will be responsible for advancing the modernization and transformation of clinical operations across Amgen's global development portfolio by enabling a connected, interoperable, and data-driven GDO clinical systems landscape. This leader will drive the integrated transformation of GDO's emerging technologies, AI-enabled capabilities, process digitization, and optimization initiatives through end-to-end technology integration and trusted digital data flow across Digital Protocol, CTMS, EDC, CDR/DQS, eCOA, IRT, eConsent, RBQM, and other critical clinical platforms. This role serves as the integration and data flow lead for GDO's Strategic Business Plan, including D2 (Differentiated Delivery), ACT FAST, and TWFS transformation initiatives. The Senior Director – Integration and Digital Data Flow will be accountable for defining and enabling a logically sequenced execution roadmap that connects digitized protocol, the Veeva Clinical ecosystem, CDR/DQS, eCOA, IRT, eConsent, and RBQM capabilities into a cohesive, enterprise-ready clinical development ecosystem. This leader will drive the convergence of digital protocols, connected clinical operations, integrated data review, cross-vault collaboration, and AI-ready data foundations to accelerate study start-up, improve trial quality, reduce cycle times, strengthen operational decision-making, and establish an industry-leading data-driven clinical development platform for GDO. Working in close partnership with Veeva, AI&D, DTI, Clinical Development, GDO, Data Management, RBQM, Regulatory, and other enterprise stakeholders, this role will shape the future operating model for clinical trial execution by ensuring technology, process, data, and governance are integrated by design. Strategic Leadership Own the integration strategy for GDO: Define the GDO’s integrated vision, strategy, and end-to-end transformation roadmap for the Clinical Data Landscape ensuring alignment across GDO, R&D AI&D, DTI and business stakeholders. Lead strategic partnership with AI&D and DTI: Serve as GDO’s relationship owner AI and Data organization of R&D, in a close collaboration with DTI for city planning, enterprise architecture, compliance and Security, influencing product direction, co-innovating future capabilities, shaping roadmap priorities, and ensuring Amgen’ GDO remains at the forefront of innovation. Establish the integrated roadmap for GDO systems and data flow : produce and maintain quarterly published artifact demonstrating single source of truth for an integrated GDO landscape depicting every single upstream and downstream consumption is fully compliant with R&D strategy Establish seamless and best of breed clinical data flow: Design and govern the end-to-end data flow architecture across all clinical platforms, SaaS applications, operational systems, analytical environments, and enterprise capabilities to enable seamless, trusted, and real-time exchange of data. Shape the external & internal technology landscape: Continuously assess emerging technology trends, competitive practices, regulatory developments, and innovation opportunities externally and internally to drive GDO’s future ready ambitions. Execution and Delivery of Strategic Business Plan • Execute the integration strategy and delivery plan : Be accountable for delivery of Strategic Business Plan priorities that create a digitally integrated, logically sequenced, and execution-ready GDO clinical systems landscape with efficient, governed, and scalable data flow. • Partner with AI&D to build AI-ready data foundations : Collaborate with AI&D, DTI, and business stakeholders to build the Clinical and Clinical Operations nodes of the Clinical Data Foundation, enabling GDO and R&D's AI, analytics, and agentic ambitions. • Drive continuous improvement of integration and data flow : Champion ongoing optimization and revitalization of existing integrations, data flow, and system interoperability while defining a clear strategy that protects primary systems for primary use and positions Clinical Data Foundation for downstream consumption. • Ensure audit-ready clinical systems and data pathways : Ensure transformation initiatives incorporate quality, compliance, security, traceability, and regulatory requirements by design, enabling audit-ready clinical vaults, governed data movement, and inspection-ready evidence across the integrated landscape. 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 degree and 15+ years of experience in clinical data landscape transformation, clinical systems integration, digital data flow, or technology-enabled clinical operations transformation OR Bachelor's degree and 18+ years of experience in clinical data landscape transformation, clinical systems integration, digital data flow, or technology-enabled clinical operations transformation AND 5+ years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of enterprise resources. Preferred Qualifications: 15+ years of experience in clinical development, clinical operations, clinical systems, data strategy, large-scale technology transformation, or related functions within the biopharmaceutical industry. Demonstrated success leading enterprise transformation initiatives involving technology integration, process modernization, data flow optimization, organizational change management, and business capability development. Experience implementing and scaling AI-enabled solutions, automation, advanced analytics, data foundations, and digital capabilities within clinical development or other regulated environments. Proven ability to lead complex cross-functional strategic initiatives that require alignment across business, technology, data, architecture, compliance, vendor, and operational teams. Experience leading at least one major transformation, migration, or integration program involving foundational clinical systems or enterprise clinical data platforms. Technical knowledge of clinical systems, SaaS platforms, integration architecture, digital health, informatics, AI-enabled capabilities, and enterprise data strategies that advance ways of working within the clinical trial ecosystem. Core Competencies: Enterprise cross-functional leadership across clinical data landscape with deep functional process expertise. Deep understanding of clinical operations technologies, AI-enabled capabilities, automation, digital platforms, and enterprise data strategy. Expertise leading large-scale transformation initiatives, of process and foundational technologies for Global Development Operations Experience driving process, data, and technology transformation, digital enablement, and organizational change management within highly matrixed environments. Strategic thinking with the ability to advance business performance through innovation, technology transformation and adoption, and modernization of clinical operations capabilities. 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. .