Senior Director, Observational Research, CPSO

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, Observational Research, CPSO What you will do Let’s do this. Let’s change the world. The Senior Director, Observational Research is a global leadership role within Clinical Program Strategy & Operations (CPSO), providing leadership for the Observational Research function and serving as the global clinical operational leader for Amgen's observational research evidence generation portfolio. The role leads clinical operational strategy and execution across observational research, pragmatic clinical trials, and other fit-for-purpose evidence generation approaches, ensuring operational delivery aligns with product evidence generation objectives and Global Development Operations (GDO) standards. Working in partnership with Product Teams, Evidence Generation Teams, the Center for Observational Research (CfOR), Global Medical Organization, Regional and Country Operations, and other GDO functions, the Senior Director translates evidence generation strategies into operationally robust delivery models that support quality, efficiency, and execution throughout the product lifecycle. As the functional leader for Observational Research, the Senior Director establishes the operating model, develops organizational capability, leads workforce and succession planning, and drives continuous operational improvement while leveraging existing GDO governance, systems, and quality standards. Responsibilities: Lead clinical operational strategy and execution across the Observational Research portfolio, ensuring alignment with product evidence generation objectives, Clinical Development Plans (CDPs), and Evidence Generation Plans (EGPs). Translate evidence generation strategies into operationally feasible delivery models supporting observational research, pragmatic clinical trials, and other fit-for-purpose evidence generation approaches. Lead portfolio operational planning, execution, governance, and performance across all Observational Research activities. Direct operational input into Evidence Generation Plans, Key Design Elements (KDEs), protocols, feasibility assessments, and study operational documentation. Develop portfolio operational plans, timelines, resource forecasts, and budget strategies in collaboration with Product Teams and Finance. Lead portfolio risk identification, mitigation planning, and operational issue resolution throughout evidence generation planning and execution. Establish standardized clinical operational approaches that support consistency, quality, and execution across the portfolio. Lead vendor strategy, outsourcing models, governance, and performance management for Real-World Evidence Clinical Operations. Represent Real-World Evidence Clinical Operations within Product Teams, governance forums, and cross-functional operational reviews. Establish strategic partnerships with the Center for Observational Research (CfOR) to ensure effective translation of scientific evidence generation strategies into operational execution. Partner with Regional and Country Operations to ensure operational feasibility, regional insight, and consistent global execution. Lead inspection readiness, audit preparedness, and implementation of corrective and preventive actions across the function. Direct portfolio operational performance monitoring, enrollment strategy, recruitment forecasting, and delivery metrics. Lead organizational design, workforce planning, and succession planning for the Real-World Evidence Clinical Operations function. Develop organizational capability through leadership development, coaching, performance management, and competency development. Allocate functional resources to support portfolio priorities and evolving evidence generation requirements. Establish functional priorities, operating principles, and standardized operational practices across the organization. Drive operational excellence through continuous improvement initiatives, operational innovation, and adoption of scalable delivery models. Evaluate emerging operational approaches, technologies, and digital capabilities that strengthen portfolio execution. Represent Clinical Program Strategy & Operations in cross-functional initiatives supporting operational excellence across Global Development Operations. Foster an inclusive, collaborative, and high-performing organizational culture that promotes accountability, innovation, and continuous learning. Drive continuous evaluation and evolution of the Observational Research capability to support future evidence generation methodologies. Relationships/Reporting Line Reports to: · Clinical Program Strategy & Operations Therapeutic Area Head Direct Reports: · Associate Directors, Senior Managers and other Observational Research staff, as appropriate. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate degree and 5 years of clinical research, clinical operations, and/or real-world evidence experience OR Master's degree and 9 years of clinical research, clinical operations, and/or real-world evidence experience OR Bachelor's degree and 11 years of clinical research, clinical operations, and/or real-world evidence experience In addition to meeting one of the above requirements, a minimum of 5 years of direct people management and/or leadership experience leading global teams, programs, portfolios, or organizational functions. Leadership experience may run concurrently with the required technical experience. Preferred Qualifications: Advanced degree (MD, DO, PhD, PharmD, or Master's degree in a scientific, healthcare, or related discipline). 10+ years of experience within the biopharmaceutical industry, including significant experience supporting global clinical development and evidence generation. Demonstrated leadership of global clinical operations across complex development programs and/or evidence generation portfolios. Experience leading observational research, in particular, pragmatic clinical trials, and other real-world evidence generation approaches within a pharmaceutical or biotechnology environment. Experience developing and implementing clinica