Purpose / Accountabilities

• Country/hub leader of Global Study Operations / Site Management (GSO-SM)

organization that is accountable for timely, quality clinical study delivery.

• Actively partners with cross-functional stakeholders to support R&D strategy.

Responsibilities

• Leadership of GSO-SM team in country/hub

• Align and lead country /hub in accordance with Amgen strategy, driving One

Amgen-

• Supporting-leading local and global process improvement & transformational

initiatives

• Developing strategy for study placement in country/ hub and maintaining

knowledge of the country capabilities

• Accountable for country/hub operational landscaping activities and final site

selection

• Review and approve Operational Projections, Baseline and Revised EnrolmentPlans

• Represent GSO-SM in internal and external stakeholder interactions

• Participate in external engagement activities (e.g. pharma associations,

Consortiums)

• Point for escalation for resolution of complex clinical study related issues & risks identified

• Locally accountable for execution of clinical studies

• Lead delivery of pipeline molecule programs

• Ensure timely, quality communication to both functional / cross-functional teams to support clinical study execution

• Partner with GSO-SM FSP and GCPM / Early Dev Clin Ops organization to monitor study progress and drive local action plans & issue resolution

• Support ISSs execution & partner with medical to design and execute LASTs

• Provide local expertise through tools or upon request

• Risk mitigation and quality management

• Proactively identify risks and develop risk mitigation strategies to ensure operational effectiveness

• Interpret analytics to monitor clinical study delivery (timelines, enrollment, data flow,

TMF)

• Oversee quality and ensure country/hub deliverables in accordance with ICH-GCP, Amgen standards and Local Regulations

• Support internal/affiliate and site audits and regulatory inspections

• Support local and global process improvement initiatives

• Performance management of local staff and oversight of GSO-SM Functional

Service Provider(s) (FSP)

• Partner with RH to maintain appropriate resource levels and manage within

budget

• Interpret resource supply and demand and ensure efficient resource allocation

• Engage local cross-functional teams to maximize local support of clinical studies

• Maintain relevant therapeutic knowledge and clinical research best practices

• Provide information and request support as needed