Career Category

Clinical

Job Description

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

.