Executive Director, Global Site & Study Operations, Americas

Job description

Career CategoryClinicalJob 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, and 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. Executive Director, Global Site Study Operations, Americas What you will do Let’s do this. Let’s change the world. In this vital role as Executive Director, Global Site Study Operations, America you will be accountable for regional Study & Site Operations leadership across the Americas clinical trial portfolio. This role provides enterprise-level strategic direction, operational oversight, people leadership, and cross-functional influence to ensure high-quality, timely, compliant, and predictable trial delivery. The role leads regional and country/hub leaders, shapes site engagement and monitoring strategies, and represents the region in global governance and portfolio decision-making forums. Key Responsibilities Oversees countries and regions within the Americas including US, Canda, and LATAM. Operates at an enterprise leadership level and is expected to combine portfolio-level strategic leadership, operational accountability, people leadership, and cross-functional influence. Initiation, management, quality, and completion of Phase I-IV clinical trials in the region, ensuring timely, high-quality delivery in compliance with ICH-GCP, regulatory requirements, and company policies. Guiding the organization on modern site-monitoring approaches and associated resource strategies. Represent the region and/or GSSO in enterprise forums, providing insights that inform portfolio, program, and study-planning decisions Build and develop a high-performing Country/Hub head team as strategic leaders, creating a culture of accountability, innovation, and operational excellence in their regions. Champion innovation and continuous improvement in start-up approaches, embedding digital solutions, predictive analytics, and harmonized ways of working across the global portfolio. Leadership and Delivery Accountable for implementing the Regional Study & Site Operations strategy ensuring that study resources are appropriately allocated according to global operations and priorities. Optimize deployment of resources, including internal and staff augmented, across clinical programs. Interpret and cascade GDO strategies into consistent regional and country-level delivery of studies, site engagement, and monitoring against quality standards, and other cross-functional processes and initiatives, balancing standardization with local/regional adaptability. Provide executive oversight of high-risk or strategically important clinical programs. Act as the GSSO escalation point for study risks and issues, coaching teams through mitigation strategies and scenario planning, ensuring timely resolution and visibility. Build and sustain a CRA monitoring organization, including resourcing strategies and portfolio considerations, while ensuring monitoring standards and organizational capabilities are in place. Ensure monitoring strategies incorporate, in partnership with relevant cross-functional capabilities, the appropriate use of centralized monitoring, on-site and remote monitoring, targeted SDR/SDV, and risk/quality indicators and thresholds. Lead through an evolving site engagement model, executing strategies that strengthen relationships with clinical research sites, improve site experience, and enhance site performance across clinical development programs. Holds decision-making authority for all study and site operations in the region, including resource allocation, budget utilization, and vendor performance. Maintain oversight of the regional clinical trial portfolio, including study start-up, enrollment, execution, database lock, and study closeout. Coach and mentor teams in management of challenges and issue escalation. Ensure appropriate inspection readiness throughout the clinical trial lifecycle and follow through to audits and inspections in the region. Represents GSSO and/or the region in global governance bodies with delegated authority to influence portfolio decisions, timelines, and resourcing. Capability Building & People Leadership Lead, coach, and develop regional and country Study & Site Operations leaders, including performance management, succession planning, and leadership bench development. Build the organizational capabilities, resourcing, and operating model needed to meet current and future regional portfolio requirements. Foster a high-performing, inclusive, accountable, and patient-focused culture across geographically distributed teams. Lead organizational changes and enable adoption of new operating models, technologies, monitoring approaches, and clinical development practices. Foster a culture of accountability, collaboration, inclusion, quality, continuous improvement, and patient focus. Lead organizational change and support adoption of new operating models, technologies, and clinical development approaches. Operational Excellence & Cross-Functional Engagement Lead, coach, and develop regional and country Study & Site Operations leaders, including performance management, succession planning, and leadership bench development. Build the organizational capabilities, resourcing, and operating model needed to meet current and future regional portfolio requirements. Foster a high-performing, inclusive, accountable, and patient-focused culture across geographically distributed teams. Lead organizational changes and enable adoption of new operating models, technologies, monitoring approaches, and clinical development practices. Identify opportunities to simplify processes, improve productivity, and increase predictability of clinical trial delivery. Use data and performance insights to drive decisions and continuous improvement. Lead or sponsor regional and global clinical operations transformation initiatives. Embed a center of excellence mindset, encouraging knowledge-sharing and best practice adoption globally. Stakeholder Engagement & Influence Partner with leaders across Clinical Development, Operations, Regulatory, and Regions to ensure study start-up strategy enables trial success, and resources required to execute are assigned and aligned to GSSO. Maintain and strengthen cross-functional and global business relationships, representing GSSO. Act as a visible change leader, promoting GSSO as a strategic enabler of faster, more predictable clinical trial execution and drive cross-functional sponsorship. Cultivate leadership and capability across geographies to build resilient, empowered teams that consistently deliver results. Authority Accountable for regional level oversight and delivery of clinical trials. Holds line management authority for regional and country operations leaders, including performance management, talent development, succession planning, and capability building. Sets regional delivery goals, operating expectations, and performance standards across study start-