At a Glance
- Tasks: Lead global teams to ensure high-quality evidence in clinical studies and drive operational excellence.
- Company: Join Amgen, a pioneering biotech company dedicated to serving patients with serious illnesses.
- Benefits: Competitive salary, comprehensive benefits, and a supportive culture for personal and professional growth.
- Other info: Inclusive workplace focused on ethical practices and continuous improvement.
- Why this job: Make a real impact on patients' lives while advancing your career in a collaborative environment.
- Qualifications: Experience in life sciences, leadership skills, and expertise in TMF operations and regulatory compliance.
The predicted salary is between 90000 - 110000 £ 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.
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.
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 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.
Director, Study Evidence & Readiness 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
✨Get Involved in Local Research Communities
Tap into local biotechnology meetups and research forums. These are great places to mingle with industry professionals, share your passion, and even discover unadvertised job openings. It's all about getting your face known in the field!
✨Leverage University Alumni Networks
If you're a recent grad, don’t underestimate the power of your university’s alumni network! Reach out to alumni working in biotechnology to gather tips about job openings at companies like Amgen. You'd be surprised how willing people are to help out a fellow grad!
✨Show Off Your Projects
Curate a portfolio showcasing any research projects or internships you've completed in biotechnology. This tangible evidence of your skills can really impress employers when you chat with them at networking events or interviews. It's about making that killer first impression!
✨Stay Up-to-Date with Industry Trends
Biotech is a fast-paced field, so keeping yourself updated with the latest advancements is crucial. Attend industry conferences, webinars, or workshops to broaden your knowledge and meet potential employers. Plus, it’ll give you fantastic talking points for your interviews at places like Amgen!
We think you need these skills to ace Director, Study Evidence & Readiness
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show Amgen that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at Amgen.
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that Amgen does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at Amgen
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at Amgen. You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into Amgen's culture.
✨Research Recent Biotech Innovations
Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at Amgen. This shows your passion for the industry!
