Senior Director, Clinical Risk & Insights

1027 Amgen Limited; Cambridgeshire and Peterborough; Sur place; GBP 120 000 - 180 000; Plein temps

Résumé du poste

Amgen Inc. is seeking a Senior Director of Clinical Risk and Insights to lead systemic investigations, RCA, and risk intelligence across Global Development Operations. You will establish standards, oversee complex investigations, and translate findings into strategic actions for senior leadership.

The role requires extensive biopharmaceutical experience, GCP knowledge, and strong leadership to drive CAPA effectiveness and cross-functional improvements across the organisation.

Qualifications

• Extensive experience in biopharmaceutical clinical development, Clinical Operations, or clinical quality.
• GCP knowledge and clinical trial execution expertise.
• Ability to translate complex risk insights into actionable recommendations.
• Strong strategic leadership and cross-functional influence.
• Experience driving organisational change and CAPA effectiveness.

Responsabilités

• Lead the GDO-wide RCA strategy and establish investigation standards.
• Oversee complex, cross-portfolio clinical investigations and prioritisation.
• Provide risk insights to senior leadership and governance forums.
• Drive CAPAs and sponsor cross-functional improvements to systemic risks.

Connaissances

RCA investigations

Clinical risk management

CAPA effectiveness

GCP knowledge

Stakeholder management

Formation

University degree required

Description du poste

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.

Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and delivery 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.

SENIOR DIRECTOR CLINICAL RISK AND INSIGHTS

What you will do

Let’s do this. Let’s change the world.

In this vital role you will lead the Clinical Risk & Insights function, driving systemic investigations, root cause analysis (RCA), and clinical risk intelligence to strengthen clinical trial execution, inform strategic decisions, and enable continuous improvement across Global Development Operations (GDO).

Define and lead the GDO-wide RCA strategy, establishing investigation standards, methodologies, and capabilities to identify systemic risks and prevent recurring issues.

Oversee complex and cross-portfolio clinical execution investigations, ensuring effective issue prioritisation, escalation, and resolution.

Provide strategic risk insights and recommendations to senior leadership and governance forums, translating investigation findings and emerging trends into actionable decisions.

Drive sustainable corrective and preventive actions (CAPAs), challenging ineffective solutions and sponsoring cross-functional improvements to address systemic risks.

Lead the Risk-Based Quality Management (RBQM) strategy, integrating systemic learning and portfolio risk intelligence into proactive risk identification and clinical trial execution.

Lead and develop a high-performing team, overseeing strategic priorities, talent development, resources, budgets, and organisational RCA capabilities.

Build strong cross-functional partnerships across GDO, Clinical Compliance, R&D Quality, study delivery teams, and external stakeholders to strengthen governance, risk management, and operational excellence.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

What we seek in you

• Degree educated
• Extensive experience in biopharmaceutical clinical development, Clinical Operations, or clinical quality, with strong knowledge of GCP and clinical trial execution.
• Proven expertise in RCA, complex cross-functional investigations, systemic risk identification, and CAPA effectiveness.
• Ability to translate complex clinical risk insights into actionable recommendations for senior leadership and governance forums.
• Strong strategic leadership, stakeholder management, and influencing skills, with experience driving cross-functional improvement and organisational change.
• Experience in clinical risk management or Risk-Based

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, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Amgen is an Equal Opportunity Employer

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen