This role serves as a strategic business technology enabler, connecting clinical development objectives with modern digital capabilities, standards, and AI-driven innovation. Leader in this role will deliver on GDO’s Strategic Business Plan which includes D2 (Differentiated Delivery), ACT FAST and TWFS transformation initiative. The Director – Digital Protocol is accountable for defining and executing on the aspiration journey of not only enabling the digitally authoring the protocol but also ensuring that Amgen stays course to enable digital consumption of protocol in the clinical trial life cycle.
Strategic Leadership
Own the Enterprise Digital Protocol Vision and Strategy: Define and lead Amgen's enterprise strategy for Digital Protocol, transforming protocols from static documents into structured, reusable, standards-driven assets that enable downstream automation, interoperability, and AI-driven study execution.
Drive Protocol Simplification and Complexity Reduction: Establish governance, standards, and operating principles that reduce protocol complexity, improve study quality and feasibility, and enhance operational efficiency across the clinical trial lifecycle.
Champion Standards Transformation and USDM Adoption: Lead adoption of USDM and industry protocol metadata standards to enable machine-readable protocol content and seamless interoperability across the clinical systems ecosystem.
Shape the Digital Protocol Product Roadmap: Serve as business product owner for Farro and related protocol authoring capabilities, defining platform strategy, feature prioritization, vendor partnerships, and long-term value realization.
Drive Enterprise Alignment Across Clinical Development Functions: Partner across Clinical Development, Clinical Operations, Data Management, Medical Writing, Biostatistics, Regulatory, AI&D, DTI, and Digital teams to align protocol transformation initiatives with broader business objectives.
Influence Industry Innovation and Digital Protocol Standards: Represent Amgen in industry forums, standards organizations, and strategic partnerships to advance the future of digital protocols, protocol metadata standards, and AI-enabled clinical development.
Execution and Delivery Leadership
Lead the implementation and scale-up of digital protocol authoring capabilities, including Farro deployment, business adoption, process readiness, and integration into end-to-end clinical development ways of working.
Deliver practical pathways for downstream digital protocol consumption, partnering across EDC, DQS, operational systems, statistical analysis, CSR generation, and regulatory submission processes to turn protocol content into reusable clinical data assets.
Establish execution roadmaps, feasibility assessments, and implementation plans that translate digital protocol strategy into phased delivery milestones, measurable outcomes, and scalable enterprise adoption.
Define and track value-based KPIs and business outcomes, including reduction in study start-up timelines, protocol amendments, operational complexity, downstream build effort, and increased automation across clinical development processes.
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 and its technology transformation 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, business transformation, large scale technology and business process transformation, 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.
Demonstrated experience leading at least one large-scale clinical systems transformation, platform implementation, or enterprise technology modernization initiative
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 digital protocol authoring, clinical operations technologies, metadata standards, AI-enabled capabilities, automation, interoperability frameworks, 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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