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 – Amgen’s Clinical Vaults
What you will do: In this vital role as Senior Director, Amgen’s Clinical Vaults, you will be responsible for advancing the modernization and transformation of clinical operations across Amgen’s global development portfolio. This leader will drive strategic innovation and implementation through adoption of emerging technologies, AI-enabled capabilities, process digitization and optimization initiatives in our CTMS, EDC and DQS ecosystems that improve quality, speed, efficiency, and scalability of clinical trial execution. This role serves as the transformation and business product lead for the GDO’s Strategic Business Plan which includes D2 (Differentiated Delivery), ACT FAST and TWFS transformation initiative. The Senior Director, Amgen X Vault Platform is accountable for defining and executing Amgen's strategy for the Veeva Clinical ecosystem, encompassing CTMS, EDC, and DQS including the transitionary period between legacy EDC.
This leader will drive the convergence of digital protocols, connected clinical operations, integrated data review, and cross-vault collaboration to accelerate study startup, improve trial quality, and establish an industry-leading, data-driven clinical development platform. Working in close partnership with Veeva, AI&D, DTI, Clinical Development, GDO, RBQM, and Regulatory teams, this role will shape the future operating model of clinical trial execution leading to cycle time reduction.
Strategic Leadership · Own the cross clinical vaults strategy: Define and execute Amgen's R&D and GDO strategy for clinical vaults, positioning CTMS, EDC and DQS as integrated, standard-driven platforms that enable consistent clinical execution and reusable data assets. · Lead Strategic Partnership with Veeva: Serve as Amgen's executive relationship owner for the Veeva clinical ecosystem, influencing product direction, co-innovating future capabilities, shaping roadmap priorities, and ensuring Amgen remains at the forefront of platform adoption and innovation. · Be part in defining the strategy for business functions: Be the embedded part of Study Start-Up, Study Operations and Data Management to be part of defining the functional strategy under Strategic Business Plan of GDO · Define Seamless Clinical Data Flow: Establish an integrated digital data flow from protocol to study planning and design through study execution, acquisition, data review enabling a seamless analysis and regulatory submission readiness.
• External Technology Landscape Leadership: Continuously assess emerging technology trends, competitive practices, regulatory developments, and innovation opportunities across the CTMS, EDC and DQS technology ecosystem; translate insights into strategic recommendations that position Amgen as a digital leader in clinical development.
Execution and Delivery of Strategic Business Plan
• Be accountable for executing on the strategy and plan: Be accountable for delivery of all strategic business plan elements fully integrated with the platform strategy of CTMS, EDC and DQS roadmap
· In close Collaboration with AI&D: Partner with AI&D, IT and business stakeholders to develop and deploy AI-enabled workflow, automation and intelligence capabilities that improve quality, speed, consistency and reuse.
• Continuous Improvements: Champion continuous improvement and transformation initiatives that simplify operations, standardize processes, and strengthen organizational effectiveness.
• Audit Ready Clinical Vaults: Ensure transformation initiatives incorporate appropriate quality, compliance, and regulatory considerations and is always audit ready through cross-functional partnership and governance.
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 data landscape transformation execution experience OR · Bachelor’s with 18+ years of clinical data landscape transformation execution experience AND · 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications:
· 15+ years of experience in clinical development, clinical operations, operational excellence, business transformation, program management, or related functions within the biopharmaceutical industry. · Demonstrated success leading large-scale enterprise transformation initiatives, including tech transformation, process modernization, organizational change management, and business capability development. · Experience implementing and scaling AI-enabled solutions, automation technologies, advanced analytics, and digital capabilities within clinical development or other regulated environments. · Proven ability to establish and lead as a business product owner supporting complex, cross-functional strategic initiatives and program execution. · Should have lead at least 1 major transformation/Migration of CTMS, EDC and CDR/DQS · Technical Knowledge: Experience with AI, digital health and informatics tools that may 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.
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