At a Glance
- Tasks: Lead global Study Evidence & Readiness, ensuring high-quality clinical study evidence.
- Company: Join Amgen, a pioneering biotech company dedicated to serving patients.
- Benefits: Competitive salary, comprehensive rewards, and a supportive culture for growth.
- Other info: Inclusive environment with opportunities for professional development and ethical commitment.
- Why this job: Make a real impact on patients' lives while advancing your career in biotech.
- Qualifications: Experience in life sciences, leadership skills, and expertise in TMF Operations.
The predicted salary is between 99000 - 121000 £ per year.
Join Amgen’s Mission of Serving Patients. 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 global Study Evidence & Readiness function, shaping departmental strategy and overseeing operational delivery across Trial Master File (TMF) Operations and Inspection Readiness. You will ensure clinical studies maintain complete, reliable, and high-quality evidence, supporting regulatory compliance, operational excellence, and continuous inspection readiness.
- Define and execute the strategy for TMF Operations and Inspection Readiness, ensuring alignment with clinical portfolio priorities and regulatory requirements.
- Lead, develop, and inspire global teams, driving performance, talent development, succession planning, and operational excellence.
- Oversee TMF quality and inspection readiness across the study portfolio, identifying evidence gaps, managing risks, and driving timely remediation.
- Manage functional operations, including resources, budgets, capacity planning, suppliers, training, and business continuity.
- Drive continuous improvement of TMF processes, standards, SOPs, and systems to strengthen evidence quality, accessibility, and compliance.
- Partner with cross-functional stakeholders to resolve complex evidence issues, address root causes, and implement sustainable improvements.
- Establish performance metrics and provide strategic insights to senior leadership on evidence quality, inspection readiness, risks, and portfolio trends.
- Provide strategic oversight of audits and regulatory inspections, ensuring effective preparation, response coordination, and implementation of lessons learned.
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.
- Proven experience in life sciences or a related field, including biopharmaceutical clinical research (pharma, biotech, or CRO).
- Proven leadership experience managing and developing teams, including management-level professionals.
- Strong expertise in TMF Operations, inspection readiness, regulatory inspections, and external vendor oversight.
- In-depth knowledge of global GCP requirements, clinical trial documentation, regulatory compliance, and risk-based oversight.
- Experience managing cross-functional projects, budgets, resources, timelines, and quality metrics within a matrix organization.
- Strong strategic leadership, stakeholder management, change management, and communication skills.
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.
Director, Study Evidence & Readiness 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 Director, Study Evidence & Readiness 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.
✨Join Relevant Professional Bodies
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.
✨Tailor Your Approach
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 Director, Study Evidence & Readiness 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.
