At a Glance
- Tasks: Lead clinical risk investigations and drive improvements in clinical trial execution.
- Company: Join Amgen, a pioneering biotech company dedicated to serving patients.
- Benefits: Competitive salary, comprehensive benefits, and a supportive culture for personal growth.
- Other info: Inclusive workplace focused on ethical practices and continuous improvement.
- Why this job: Make a real impact on patient lives while advancing your career in a collaborative environment.
- Qualifications: Extensive experience in biopharmaceutical development and strong leadership skills required.
The predicted salary is between 72000 - 88000 £ per year.
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.
What you will do
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. Apply now and make a lasting impact with the Amgen team.
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.
Senior Director, Clinical Risk & Insights in Cambridge employer: Amgen
At Amgen, we pride ourselves on being a leading biotechnology company that prioritises the well-being and growth of our employees. As an EU Regulatory Affairs Manager, you will be part of a diverse and inclusive team dedicated to serving patients, with ample opportunities for professional development and a generous Total Rewards Plan. With flexible working arrangements from our offices in Cambridge, Uxbridge, or Lisbon, you can enjoy a fulfilling career while maintaining a healthy work-life balance.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Director, Clinical Risk & Insights in Cambridge
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Amgen. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Amgen.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Amgen. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
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When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Amgen is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Senior Director, Clinical Risk & Insights in Cambridge
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Amgen!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Amgen that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Amgen!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Amgen, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Amgen
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Amgen that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Amgen’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
