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Amgen Logo Amgen · Research and Development

Executive Director, Study Start-Up

United States, Thousand Oaks 281634.00 - 336501.00 USD / Year · Job Posted February 06, 2026
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Job Description

In this vital role as Executive Director, Study Start-Up (SSU), you will lead SSU Hub as a global center of excellence, and define and oversee the global SSU capability strategy, synthesizing sub-function strategies into a cohesive operating model that accelerates timeliness and drives consistent quality across all new studies. You will ensure operational consistency and scalability of study start-up delivery across all programs and therapeutic areas. Represent the SSU Hub in enterprise and governance forums, influencing portfolio decisions and ensuring start-up insights to inform program and study planning. You will champion innovation and continuous improvement in start-up approaches, embedding digital solutions, predictive analytics, and harmonized ways of working across the global portfolio.

Job Responsibility

  • Shape the long-term vision and strategy of the SSU Hub, ensuring alignment with CPSO, GDO, and enterprise priorities
  • Integrate and harmonize strategies from the six sub-functions into a single global capability strategy, balancing standardization with local/regional adaptability
  • Act as the global escalation point for study start-up risks and issues, ensuring timely resolution and portfolio-level visibility
  • Embed within the industry - bringing outside ways of working and representing Amgen back into the industry
  • Build and develop a high-performing global SSU leadership team (Directors, Sr Managers) creating a culture of accountability, innovation and operational excellence
  • Lead, and mentor the global SSU Hub leadership team, ensuring robust succession planning, talent development, and organizational effectiveness
  • Drive consistent performance management, alignment, and calibration across sub-functions to ensure equitable resourcing and delivery
  • Embed a center of excellence mindset, encouraging knowledge-sharing and best practice adoption globally
  • Oversee start-up planning and execution across all new studies globally, ensuring timelines and quality standards are consistently achieved
  • Partner with Clinical Program Strategy and Operations TA Heads to ensure seamless integration of start-up into program execution
  • Monitor and report global SSU performance through clear metrics and KPIs, driving accountability for continuous improvement
  • Maintain and strengthen cross-functional and global business relationships, representing the SSU Hub in governance forums and enterprise initiatives
  • Partner with senior 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 SSU hub plan
  • Act as a visible change leader, promoting the SSU Hub’s role as a strategic enabler of faster, more predictable clinical trial execution and drive cross functional sponsorship

Requirements

  • Doctorate degree and 6 years of clinical execution experience
  • Master’s degree and 10 years of clinical execution experience
  • Bachelor’s degree and 12 years of clinical execution experience
  • 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
  • 12+ years’ work experience in life sciences industry, particularly focusing on clinical trial work, including 10+ years of biopharmaceutical clinical research experience obtained at a biotech or pharmaceutical company
  • Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials
  • Experience driving and leading organizations through cross-functional change initiatives such as identifying solutions to problems and innovating and change strategies and structure to meet future needs
  • Experience leading cross-functional / cross-geography / cross-trial teams, ensuring operational excellence and smooth decision-making
  • ability to escalate and resolve challenges in alignment with global study strategy priorities
  • Extensive knowledge of the clinical and pharmaceutical drug development process, from early to late-stage development with a deep understanding of relevant therapeutic areas to meet the highest scientific and regulatory standards
  • Adept in cross geography, cultural dynamics and running efficient global teams - Ability to lead and motivate geographically dispersed teams in an inclusive manner
  • Experience in assessing internal capabilities and identifying key capabilities to build training content, monitoring skill improvement, and drive competency builds across function and within teams
  • Demonstrates clear understanding of how to build collaborative networks across cross-functional teams, senior management, and external stakeholders, internally and externally to drive efficiency across processes
  • Big picture, proactive thinking with the ability to assess broad impacts across multiple product portfolios to identify innovative solutions

What we offer

  • 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, including remote work arrangements, where possible
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