Country Head, Global Study & Site Operations
Country Head, Global Study & Site Operations
China - Shanghai Apply NowEHULX-KQFP2-P9LYM
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, andAmgen quality standards.
Accountable for end-to-end study, site, and site engagement executionacross 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 organizationalobjectives.
Ensure adequate andtimelyresourcingacross study delivery, site operations, andmonitoringroles, working closely with global partners to match capacity and capability to portfolio demand.
Drive siteengagementthrougha 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),representingthe 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.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an individual with the following qualifications.
Basic Qualifications:
- Doctorate degree and 3 years of clinical execution experience OR
- Master’s degree and 7 years of clinical execution experience OR
- Bachelor’s degree and 9 years of clinical execution experience
- In addition to meeting at least one of the above requirements, you must have at least 3 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications:
- +8 years’ work experience in life sciences or medically related field, including 6 years of biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
- Experience at, or oversight of, clinical research vendors (CRO’s, central labs, imaging vendors, etc.)
- Significant experience managing clinical operations across relevant geography / region, including strong understanding of local regulatory requirements around global clinical trials
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, we’ll support your journey every step of the way.