Senior Director, Clinical Risk & Insights

Amgen; Cambridge; Sur place; GBP 120 000 - 180 000; Plein temps

Résumé du poste

Amgen is seeking a Senior Director Clinical Risk and Insights in the Cambridge area to lead the Clinical Risk & Insights function, strengthening trial execution and risk intelligence across Global Development Operations. You will guide RCA standards, CAPA effectiveness, and RBQM strategy while building a high-performing team and partnering across GDO and R&D stakeholders.

The role requires extensive biopharma experience, deep GCP knowledge, and the ability to translate complex clinical risks

Qualifications

• Degree educated with extensive biopharmaceutical clinical development experience.
• Strong knowledge of GCP and clinical trial execution.
• Proven RCA, cross-functional investigations, and CAPA effectiveness.

Responsabilités

• Define and lead GDO-wide RCA strategy with standards and capabilities.
• Oversee complex cross-portfolio clinical investigations and prioritisation.
• Provide strategic risk insights to senior leadership and governance forums.
• Drive CAPAs and sponsor cross-functional improvements.
• Lead RBQM strategy and integrate risk intelligence into trials.
• Build and develop a high-performing team with budget oversight.
• Foster cross-functional partnerships across GDO and external stakeholders.

Connaissances

RCA

CAPA

RBQM

GCP knowledge

Cross-functional leadership

Quality trend analysis

Stakeholder management

Clinical risk management

Strategic risk insights

Formation

Degree educated

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 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.

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 as an experienced professional, are these qualifications and skills:

• 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 Quality Management (RBQM), including risk assessments, mitigation strategies, and quality indicators.

• Experience in quality trend analysis, operational excellence, analytics, and continuous improvement.

• Experience leading teams, including managers, and overseeing budgets, resources, and organisational capabilities.

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.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of 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. 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.