Executive Director, Study Start-Up

Role Summary

Executive Director, Study Start-Up leads the SSU Hub as a global center of excellence, defining and overseeing Amgen’s global SSU capability strategy and synthesizing sub-function strategies into a cohesive operating model to accelerate timelines and deliver consistent quality across all new studies.

You will ensure operational consistency and scalability of study start-up delivery across programs and therapeutic areas, represent the SSU Hub in enterprise governance forums to influence portfolio decisions, and champion innovation by embedding digital solutions, predictive analytics, and harmonized ways of working across the global portfolio.

Responsibilities

• Strategic Leadership & Governance
  • 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.
• Capability Building & People Leadership
  • Build and develop a high-performing global SSU leadership team (Directors, Sr Managers) creating a culture of accountability, innovation and operational excellence.
  • You will 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.
• Operational Excellence & Delivery
  • 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.
• Stakeholder Engagement & Influence
  • 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.

Qualifications

• Required: Doctorate degree and 6 years of clinical execution experience OR
• Required: Master’s degree and 10 years of clinical execution experience OR
• Required: Bachelor’s degree and 12 years of clinical execution experience AND
• Required: 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
• Preferred: 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
• Preferred: Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials
• Preferred: 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
• Preferred: 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
• Preferred: 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
• Preferred: Adept in cross geography, cultural dynamics and running efficient global teams - Ability to lead and motivate geographically dispersed teams in an inclusive manner
• Preferred: 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
• Preferred: 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
• Preferred: Big picture, proactive thinking with the ability to assess broad impacts across multiple product portfolios to identify innovative solutions