Senior Manager Development Operations

Senior Manager Development Operations

What you will do

• Country/hub leader of Global Study Operations / Site Management (GSO-SM) organization that is accountable for overall country/hub delivery across studies.
• Develop and drive innovative strategies to promote an optimal clinical research environment in the country/hub
• Actively partners with multi-functional collaborators to support Amgen and R&D strategies

Leadership of GSO-SM team in country/hub

• Align and lead country /hub in accordance with Amgen strategy, driving One Amgen
• Maintain knowledge of country/hub capabilities and clinical research standard methodologies
• Represent GSO-SM in internal and external collaborator interactions
• Establish and drive local engagement strategy in coordination with local collaborators to optimize external engagements (e.g. key targeted sites, Patient Advocacy groups, Pharma Associations, Consortiums)
• Advocate for local study placement strategy in consideration of country/hub strengths and growth opportunities
• Drive process excellence, innovation and continuous improvement to accelerate study portfolio delivery
• Support and/or lead local and global process improvement & ground-breaking initiatives
• Embrace and be an advocate for change within local and global teams

• Shape and foster internal environment for optimal local cluster team collaboration
• Monitor overall health and consistency of local cluster teams interactions to enable successful delivery of pipeline molecule programs
• Partner with relevant GDO functions to monitor study progress and drive timely local action plans & issue resolution
• Point for partner concern for resolution of clinical study related issues & risks which impact delivery or quality of clinical trials and/or patient safety
• Accountable for country/hub landscaping activities and operational projections
• Required advisor for site selection and country commitments
• Ensure timely communication with multi-functional teams to support clinical study execution
• Support ISSs execution & partner with medical to design and implement LASTs

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

• Partner with RH to maintain appropriate resource levels and manage within budget
• Interpret resource supply and demand and ensure efficient resource allocation

• Proactively identify risks and develop risk mitigation strategies to ensure operational effectiveness
• Interpret analytics to monitor overall country delivery across studies (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 and drive local CAPA implementationBasic Qualifications
• Doctorate degree AND 2 years of directly-related clinical experience OR
• Masters degree & 8 to 10 years of directly-related clinical experience OR
• Bachelors degree (BA/BS/BSc or RN) & 10 to 14 years of directly-related clinical experience OR
• Diploma & 14 to 18 years of directly related clinical experience AND
• 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, Masters Degree
• 7 years work experience in life sciences or medically related field, including 8 years of biopharmaceutical clinical research experience(clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
• Experience at, or oversight of, clinical research vendors (CROs, central labs, imaging vendors, etc.)
• Country clinical operations experience and/or regional study management experienceKnowledge
• Advanced knowledge of global clinical trial management
• Clinical trial processes and operations
• In depth understanding of drug development process, clinical trialconduct, 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