Senior Director, Clinical Risk & Insights

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Career Category Clinical 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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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 RISK AND INSIGHTS What you will do Let’s do this. Let’s change the world. In this vital role you will lead the Clinical Risk & Insights function, driving systemic investigations, root cause analysis (RCA), and clinical risk intelligence to strengthen clinical trial execution, inform strategic decisions, and enable continuous improvement across Global Development Operations (GDO). Define and lead the GDO-wide RCA strategy, establishing investigation standards, methodologies, and capabilities to identify systemic risks and prevent recurring issues. Oversee complex and cross-portfolio clinical execution investigations, ensuring effective issue prioritisation, escalation, and resolution. Provide strategic risk insights and recommendations to senior leadership and governance forums, translating investigation findings and emerging trends into actionable decisions. Drive sustainable corrective and preventive actions (CAPAs), challenging ineffective solutions and sponsoring cross-functional improvements to address systemic risks. Lead the Risk-Based Quality Management (RBQM) strategy, integrating systemic learning and portfolio risk intelligence into proactive risk identification and clinical trial execution. Lead and develop a high-performing team, overseeing strategic priorities, talent development, resources, budgets, and organisational RCA capabilities. Build strong cross-functional partnerships across GDO, Clinical Compliance, R&D Quality, study delivery teams, and external stakeholders to strengthen governance, risk management, and operational excellence. What we expect of you We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills: Degree educated Extensive experience in biopharmaceutical clinical development, Clinical Operations, or clinical quality, with strong knowledge of GCP and clinical trial execution. Proven expertise in RCA, complex cross-functional investigations, systemic risk identification, and CAPA effectiveness. Ability to translate complex clinical risk insights into actionable recommendations for senior leadership and governance forums. Strong strategic leadership, stakeholder management, and influencing skills, with experience driving cross-functional improvement and organisational change. Experience in clinical risk management or Risk-Based Quality Management (RBQM), including risk assessments, mitigation strategies, and quality indicators. Experience in quality trend analysis, operational excellence, analytics, and continuous improvement. Experience leading teams, including managers, and overseeing budgets, resources, and organisational capabilities. 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,

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