Executive Director, Study

Position: Executive Director, Study Start-Up
Career Category

Clinical

Job Description

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.

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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The executive we seek is an experienced leader with the following qualifications.

Basic Qualifications:

* 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

Preferred Qualifications:

* 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

*…