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Executive Director, Global Site & Study Operations, Americas

Amgen

US California Thousand OaksStaffH-1B sponsor company
Sign in to applyVerified 1h ago
Location
US California Thousand Oaks
Work model
On-Site
Level
Staff
H-1B history
137 approvals (FY2023)
Posted
Sep 11, 2026

Skills

GCP

About this role

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. 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.

Listing verified 1h ago. Applications go through the company's official careers site.

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Executive Director, Global Site & Study Operations, Americas at Amgen, US California Thousand Oaks | Yoinka