Executive Director, Study Start-Up

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll 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

Lets do this. Lets change the 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 Hubs 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

• Masters degree and 10 years of clinical execution experience OR

• Bachelors 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

• 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

What you can expect of us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

The annual base salary range for this opportunity in the U.S. is $281634 - $336501.

In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities that may include:

• 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

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients.

Together we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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