**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