Director, Local Study Operations Manager

Job description

Career CategoryClinicalJob DescriptionJoin Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer.  As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Local Study Operations Manager (LSOM), DirectorWhat you will doLet’s do this. Let’s change the world. In this vital role you will provide strategic and operational leadership for the country LSOM organization and is accountable for the quality, timeliness, cost, and compliant execution of the country clinical study portfolio. The role achieves results through LSOM Senior Managers and their FTE and FSP teams, translating global clinical development strategy into country operating priorities. The role directs portfolio delivery, resource and capacity strategy, financial planning, quality and risk management, vendor performance, and inspection readiness from feasibility through study close-out. As a member of the country leadership team, this role influences study placement and portfolio decisions, leads the resolution of significant operational issues, develops organizational capability and succession plans, and represents LSOM operations in country, regional, and global governance forums. Accountabilities Lead the successful delivery of the country study portfolio through the LSOM management organization, ensuring alignment with global clinical development priorities. Provides strategic direction and leadership to LSOM country organization across the full study lifecycle, including feasibility, study execution, and study close-out. Establishes portfolio-level oversight of delivery, quality, risk, timelines, and performance, directing timely escalation and resolution of critical issues for LSOM management organization. Manage LSOM and LSOM vendor performance to guarantee high-quality study execution, serving as the primary escalation point for local study challenges, driving solutions, and ensuring portfolio targets are met within the country. Build leadership capability within the LSOM organization through targeted coaching, development, and succession planning, preparing LSOMs to lead increasingly complex trials and programs. Establishes strong operating partnerships with Clinical Research Associate (CRA) organization to support study start-up, monitoring, issue resolution, and compliant trial execution across the country portfolio. Cultivate a high-performing, accountable, and inclusive organization focused on operational excellence and continuous improvement. Champion strong integration between study strategy and local execution teams to translate portfolio priorities into effective country-level delivery. Strengthen cross-functional alignment and accountability across country teams to accelerate execution and deliver portfolio commitments. Influences study-placement and portfolio investment decisions by providing strategic insight into country's capabilities, operational readiness, performance, and growth potential. Anticipates portfolio-level delivery risks, quality trends, and evolving resource requirements, directing mitigation strategies and systemic improvements across country operations. Sponsor initiatives that advance operational efficiency, digital innovation, organizational capability, and the adoption of leading practices. Direct resource strategy, capacity planning, and workload allocation across FSP and FTE LSOM teams to optimize execution and align resources with global priorities. Ensure compliance with applicable regulatory, GCP, ICH, and organizational standards across the country's study portfolio. Partner with the Regional Head/Country Head and senior cross-functional stakeholders to align priorities, establish accountability for trial deliverables, and resolve significant escalations. Responsibilities Serve as the functional leader for LSOM Senior Managers and the broader LSOM team, including both FSP and FTE, to optimize trial execution and align with global priorities. including strategy and execution, managing risks and escalations Partners closely with CRAs, CSPO, Quality, and FSP partners. Leads the coordination among country functional teams to ensure successful delivery of the country portfolio. Ensure inspection readiness and provide hands-on support during inspections, including responsibility for storyboards. Sponsors continuous operational improvement initiatives and encourage sharing of best practices. Ensure compliance with relevant regulatory and quality standards. Collaborate with the Regional Head/Country Head to engage cross-functional stakeholders, align on trial deliverables, and manage escalations as needed. Capability Building and People Leadership Lead, coach, and develop LSOM Sr Managers, including performance management, succession planning, and leadership bench development. Build the organizational capabilities, resourcing needed to meet the current and future regional portfolio requirements. Foster a high-performing, inclusive, accountable, and patient-focused culture across geographically distributed teams. Lead organizational changes and enable adoption of new operating models, technologies Authority Accountable for country level oversight and delivery of clinical trials. Manage the performance of LSOM Senior Managers and their teams Holds line management authority for regional and country operations leaders, including performance management, talent development, succession planning, and capability building. Sets regional delivery goals, operating expectations, and performance standards across study start-up, site engagement, monitoring, execution, and closeout. Capability build, talent and performance management, and acting as a liaison for cultural differences within region. Outputs Manage LSOM resources in accordance with the global study strategy. Oversee resource allocation and workload balance across LSOMs. Handle FSP supplier resource coordination and monitor performance through quality oversight metrics. Identify and report any risks or compliance concerns related to FSP activities. Escalate issues to the Regional/Country Head as necessary. What we expect of you Basic Qualifications: Doctorate degree and 4 years of clinical research experience OR Master’s degree and 7 years of clinical research experience OR Bachelor’s degree and 9 years of clinical research experience Preferred Qualifications: 4 years of direct managerial and/or leadership experience or equivalent Deep knowledge of ICH GCP, ICH E6(R3), ICH E8(R1), and global regulatory expectations for risk-based monitoring and clinical trial oversight. Proven ability to influence senior stakeholders and lead complex cross-functional initiatives within a global matrix organization Strong Project Management experience Experience managing multiple teams / direct reports across multiple clinical functions / trials Experience at, or oversight of, clinical research vendors (CROs, central labs, imaging vendors, etc.) Experience managing clinical operations across relevant geography / region, including strong understanding of local regulatory requirements around global clinical