Career Category

Job Description

MAIN 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 Enrolment Plans 
  • 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
• 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 inspection readiness, internal/affiliate and site audits and regulatory inspections, including CAPA resolution 
  • Actively participates in role forums including global functional and cross-functional initiatives
  • Leads local process improvement initiatives
• Performance management of local staff and oversight of GSO-SM Functional Service Provider(s) (FSP)
  • Primary point of contact for FSP vendor(s) for resource and capacity management, portfolio planning and prioritization, performance management including the identification, escalation and resolution of quality and delivery issues
  • Partner with RH to maintain  appropriate resource levels  and manage within budget
  • Interpret resource  supply and demand and ensure efficient resource allocation
• Locally accountable for execution of clinical studies
  • Lead delivery of pipeline molecule programs
  • Performs sponsor oversight activities of SM-FSP, including capacity planning and management, staff training and performance, to ensure quality and delivery of Amgen clinical trials, as outlined in quality oversight plan
  • Oversight of the site contracting, budgeting and payment process
  • Manages SCBA staff involved in local site contracting and budget management, insurance and payment process
  • Ensure timely, quality communication to both functional / cross-functional teams to support  clinical study execution
  • Partner with GSO-SM FSP and GCPM 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
• 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

 REQUIREMENTS:

• Basic Qualifications
  • BA/BS/BSc or RN
  • Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
  • Previous management experience of direct reports, including management level staff
• Preferred Qualifications
  • M.D., D.O., PhD, PharmD, Master’s Degree
  • Experience at, or oversight of, clinical research vendors (CRO’s, central labs, imaging vendors, etc.)
  • Country clinical operations experience and/or regional study management experience
• Knowledge
  • Advanced knowledge of global clinical trial management
  • Clinical trial processes and operations
  • Extensive knowledge of ICH/GCP, local regulations, clinical trial environment, requirements, and guidelines
  • Project and Program management including oversight of quality, study deliverables, budgets and timelines
  • Various therapeutic area knowledge
  • Fluency in written and spoken English
  • Clinical trial management systems and reporting tools

COMPETENCIES:

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• Strategic operational planning and cross-functional leadership
• Horizon scanning
• Risk assessment and risk mitigation
• Issue management and escalation
• Project management
• Analytical and problem solving skills
• Decision making
• Relationship management across geographic areas, including: networking, negotiation and influencing skills across all levels with both internal/external stakeholders
• Oral and written communication
• Organizational skills: planning, time management, prioritization, delegation
• Ability to work independently as well as in a team/matrix environment on multiple projects and countries
• Performance and people management
• Change management skills and learning ability

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.