Executive Director, Study Start-Up

Amgen • Thousand Oaks, CA

1d

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. 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, Study Start-Up What you will do Let’s do this. Let’s change the world. 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.

Requirements

• Doctorate degree and 6 years of clinical execution experience OR Master’s degree and 10 years of clinical execution experience OR Bachelor’s degree and 12 years of clinical execution experience
• AND 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Nice To Haves

• 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
• They will also embody the Amgen leadership attributes which are: Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results

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 Buil 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.

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, including remote work arrangements, where possible

What This Job Offers

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