Career Category

Job Description

Senior Manager Development Operations
full time job / reporting to Medical Director CZ

Purpose of Job:

• CZ & SK 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 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
• 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

Preferred Qualifications and requirements:
MD, 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
• 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

Knowledge

• Advanced knowledge of global clinical trial management, Clinical trial processes and operations
• In depth understanding of drug development process, clinical trial conduct, ICH-GCP and local regulations, 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