US Country Head, Global Study & Site Operations Director

Role Summary

Provide strategic and operational leadership for all study and site execution within the assigned country or hub-and-spoke geography, ensuring delivery of the clinical portfolio in alignment with global study strategies, regulatory requirements, and Amgen quality standards. Lead country governance, budget and resource management, and site engagement while ensuring compliance and patient safety.

Responsibilities

• Accountable for end-to-end study, site, and site engagement execution across the assigned country or hub-and-spoke geography, delivering start-up, enrolment, retention, data quality, and patient safety outcomes in compliance with local regulations and global strategies.
• Provide strategic leadership for country commitments, acting as a key advisor on study feasibility, placement, and site selection, aligned to global portfolio priorities and regional strengths.
• Lead, line-manage, and develop the Country/Hub team, ensuring clear direction, strong performance, capability development, and succession planning to deliver portfolio and organizational objectives.
• Ensure adequate and timely resourcing across study delivery, site operations, and monitoring roles, working closely with global partners to match capacity and capability to portfolio demand.
• Drive site engagement through a clearly differentiated Amgen site experience, strengthening investigator and site relationships through strong leadership, compliance, innovation, and collaboration with global study teams.
• Oversee country-level financial and operational management, including budgets, forecasting, vendor oversight, and efficient allocation of resources to ensure accountability and value delivery.
• Lead country governance and risk management, including chairing the Country Management Team (CMT), representing the country in senior governance forums, and managing risks, issues, and escalation to protect quality and delivery.
• Ensure regulatory compliance, inspection readiness, and continuous improvement, promoting best-practice sharing, audit readiness, and adherence to ICH-GCP, SOPs, and local regulatory requirements.

Qualifications

• Required: Doctorate degree and 4 years of clinical execution experience OR Master’s degree and 8 years of clinical execution experience OR Bachelor’s degree and 10 years of clinical execution experience, plus at least 4 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources (managerial experience may run concurrently with technical experience).
• Preferred: +10 years’ work experience in life sciences or medically related field, including 8 years of biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical, or CRO company).
• Preferred: Experience at, or oversight of, clinical research vendors (CROs, central labs, imaging vendors, etc.).
• Preferred: Significant experience managing clinical operations across relevant geography/region, including strong understanding of local regulatory requirements around global clinical trials.