Executive Director, Global Site & Study Operations, Americas

Amgen • Thousand Oaks, CA

3d

About The Position

Join Amgen’s Mission of Serving Patients At 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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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. Executive Director, Global Site Study Operations, Americas What you will do Let’s do this. Let’s change the world. In this vital role as Executive Director, Global Site Study Operations, America you will be accountable for regional Study & Site Operations leadership across the Americas clinical trial portfolio. This role provides enterprise-level strategic direction, operational oversight, people leadership, and cross-functional influence to ensure high-quality, timely, compliant, and predictable trial delivery. The role leads regional and country/hub leaders, shapes site engagement and monitoring strategies, and represents the region in global governance and portfolio decision-making forums.

Requirements

• Doctorate degree & 6 years of global site study experiences OR Master’s degree & 10 years of global site study experiences OR Bachelor’s degree & 12 years of global site study experiences
• 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
• Bachelor's degree in life sciences, pharmacy, nursing, medicine, or a related discipline required
• 15+ years of progressive experience in pharmaceutical, biotechnology, CRO, or clinical research organizations.
• Extensive clinical operations and study management experience across multiple phases of clinical development.
• Significant leadership experience managing managers and/or large, geographically distributed clinical operations organizations, inclusive of a monitoring organization.
• Demonstrated experience overseeing complex global or regional clinical trial portfolios.
• Demonstrated experience with CRO/vendor governance, outsourcing models, budget management, and resource planning.
• Track record of leading organizational change and improving clinical operations performance.
• Strong knowledge of ICH-GCP, clinical development processes, and applicable regulatory requirements.
• Experience supporting regulatory inspections and clinical quality management.
• Experience working for or overseeing clinical research vendors (CROs, central laboratories, imaging vendors, etc.)
• Experience managing clinical operations across relevant geography / region, including strong understanding of local regulatory requirements around clinical trials.

Nice To Haves

• advanced degree preferred

Responsibilities

• Oversees countries and regions within the Americas including US, Canda, and LATAM.
• Operates at an enterprise leadership level and is expected to combine portfolio-level strategic leadership, operational accountability, people leadership, and cross-functional influence.
• Initiation, management, quality, and completion of Phase I-IV clinical trials in the region, ensuring timely, high-quality delivery in compliance with ICH-GCP, regulatory requirements, and company policies.
• Guiding the organization on modern site-monitoring approaches and associated resource strategies.
• Represent the region and/or GSSO in enterprise forums, providing insights that inform portfolio, program, and study-planning decisions
• Build and develop a high-performing Country/Hub head team as strategic leaders, creating a culture of accountability, innovation, and operational excellence in their regions.
• Champion innovation and continuous improvement in start-up approaches, embedding digital solutions, predictive analytics, and harmonized ways of working across the global portfolio.
• Accountable for implementing the Regional Study & Site Operations strategy ensuring that study resources are appropriately allocated according to global operations and priorities.
• Optimize deployment of resources, including internal and staff augmented, across clinical programs.
• Interpret and cascade GDO strategies into consistent regional and country-level delivery of studies, site engagement, and monitoring against quality standards, and other cross-functional processes and initiatives, balancing standardization with local/regional adaptability.
• Provide executive oversight of high-risk or strategically important clinical programs.
• Act as the GSSO escalation point for study risks and issues, coaching teams through mitigation strategies and scenario planning, ensuring timely resolution and visibility.
• Build and sustain a CRA monitoring organization, including resourcing strategies and portfolio considerations, while ensuring monitoring standards and organizational capabilities are in place.
• Ensure monitoring strategies incorporate, in partnership with relevant cross-functional capabilities, the appropriate use of centralized monitoring, on-site and remote monitoring, targeted SDR/SDV, and risk/quality indicators and thresholds.
• Lead through an evolving site engagement model, executing strategies that strengthen relationships with clinical research sites, improve site experience, and enhance site performance across clinical development programs.
• Holds decision-making authority for all study and site operations in the region, including resource allocation, budget utilization, and vendor performance.
• Maintain oversight of the regional clinical trial portfolio, including study start-up, enrollment, execution, database lock, and study closeout.
• Coach and mentor teams in management of challenges and issue escalation.
• Ensure appropriate inspection readiness throughout the clinical trial lifecycle and follow through to audits and inspections in the region.
• Represents GSSO and/or the region in global governance bodies with delegated authority to influence portfolio decisions, timelines, and resourcing.
• Lead, coach, and develop regional and country Study & Site Operations leaders, including performance management, succession planning, and leadership bench development.
• Build the organizational capabilities, resourcing, and operating model needed to meet 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, monitoring approaches, and clinical development practices.
• Foster a culture of accountability, collaboration, inclusion, quality, continuous improvement, and patient focus.
• Lead organizational change and support adoption of new operating models, technologies, and clinical development approaches.
• Lead, coach, and develop regional and country Study & Site Operations leaders, including performance management, succession planning, and leadership bench development.
• Build the organizational capabilities, resourcing, and operating model needed to meet 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, monitoring approaches, and clinical development practices.
• Identify opportunities to simplify processes, improve productivity, and increase predictability of clinical trial delivery.
• Use data and performance insights to drive decisions and continuous improvement.
• Lead or sponsor regional and global clinical operations transformation initiatives.
• Embed a center of excellence mindset, encouraging knowledge-sharing and best practice adoption globally.
• Partner with leaders across Clinical Development, Operations, Regulatory, and Regions to ensure study start-up strategy enables trial success, and resources required to execute are assigned and aligned to GSSO.
• Maintain and strengthen cross-functional and global business relationships, representing GSSO.
• Act as a visible change leader, promoting GSSO as a strategic enabler of faster, more predictable clinical trial execution and drive cross-functional sponsorship.
• Cultivate leadership and capability across geographies to build resilient, empowered teams that consistently deliver results.
• Accountable for regional level oversight and delivery of clinical trials.
• 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.
• Successful and timely trial delivery across the region with inspection-ready quality.
• Cohesive and aligned execution across countries, with consistent quality and compliance.
• Sustained regional investigator and site engagement enabled through consistent country/hub-level engagement strategies driving strong patient recruitment and retention.
• High-performing regional team with strong leadership, empowered Country Heads acting as effective strategic representatives in their geographies.
• Adept at navigating cross-geographic and cultural dynamics and leading efficient global teams.
• Demonstrated ability to motivate geographically dispersed teams inclusively and drive strategy and execution.
• Experience in delivering portfolio/cross-study level, budgets, timelines, and performance metrics (time, cost, quality) aligned to global / functional priorities.
• Collaborate with global and regional leadership to ensure effective country and site strategies guiding study start up, inspection, and delivery.
• Proficient in overseeing resource and budget allocation in accordance with functional financial principles, ensuring optimal resource planning aligned with global clinical priorities.
• Experience in assessing internal capabilities and identifying key capabilities, proficient in driving and leading continuous improvement initiatives for team's working practices, ensuring cross-functional adoption of new processes.
• Experience leading organizations through cross-functional change initiatives, including identifying solutions to complex problems, driving innovation, and evolving strategies and structures to meet future business needs.
• Proven ability to foster impactful cross-functional collaboration through exceptional communication and influence.
• Enterprise, pro-active thinking with the ability to assess broad impacts across multiple product portfolios to identify innovative solutions.
• Build strong partnerships with Clinical Development, Medical, Regulatory Affairs, Safety, Biometrics, Data Management, Clinical Supply, Quality, and other functions.
• Communicate portfolio performance, risks, and strategic recommendations clearly to senior leadership.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree