Amgen
Website:
amgen.com
Company:
https://www.linkedin.com/company/amgen
Industries: Biotechnology Research and Pharmaceutical Manufacturing
Job details:
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 oversight, and risk-based quality strategies while maintaining alignment with evolving regulatory expectations
Execution and Delivery Leadership
- Deliver and Scale RBQM Platform Capabilities: Lead implementation, adoption, and continuous enhancement of RBQM platforms and central monitoring capabilities, ensuring seamless integration into study start-up, study conduct, risk review, and quality management processes.
- Enable Cross-Functional Risk Detection and Response: Establish operational processes, dashboards, analytics, and workflows that provide study teams, SSU, SSO, and Data Management functions with actionable insights to proactively identify, assess, escalate, and mitigate risks.
- Drive Data Integration and End-to-End Operational Visibility: Deliver integrated data ecosystems that connect clinical, operational, site, quality, and risk information to support central monitoring, portfolio oversight, informed decision-making, and execution excellence.
- Measure Business Performance and Transformation Outcomes: Define and track value-based KPIs demonstrating improvements in study start-up timelines, site activation performance, monitoring effectiveness, protocol compliance, issue resolution, study quality, operational efficiency, and overall trial execution
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 12+ years of clinical data landscape transformation execution experience OR
- Bachelor’s with 15+ 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 RBQM 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 exposure to the overall global trend and understanding of regulatory requirements and RBQM based clinical trial management
- 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 RBQM principles, central monitoring methodologies, risk analytics, quality management frameworks, GCP expectations, and RBQM technology platforms supporting modern clinical trial oversight.
- 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.
Click on Apply to know more.
