Director, Study Evidence & Readiness

Amgen Inc.; England; On-site; GBP 120,000 - 180,000; Full time

Job summary

Amgen Inc. is hiring a Director of Study Evidence and Readiness to lead global TMF Operations and ensure inspection readiness across clinical studies.

You will shape departmental strategy, oversee delivery, and manage regulatory readiness and vendor oversight. You will lead diverse teams, drive performance, manage budgets and capacity, and continuously improve TMF processes to strengthen evidence quality and regulatory compliance.

Qualifications

• Degree educated.
• Proven experience in life sciences or a related field including biopharmaceutical clinical research.
• 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.

Responsibilities

• Lead the global Study Evidence & Readiness function, shaping strategy and overseeing TMF Operations and Inspection Readiness.
• Define and execute strategy for TMF Operations and Inspection Readiness aligned with regulatory requirements.
• Lead, develop and inspire global teams, driving performance and succession planning.
• Oversee TMF quality and inspection readiness, identify evidence gaps and drive remediation.
• Manage resources, budgets, capacity planning, suppliers, training and business continuity.
• Drive continuous improvement of TMF processes, standards, SOPs and systems.
• Partner with cross-functional stakeholders to resolve complex evidence issues and implement improvements.
• Establish performance metrics and provide strategic insights to senior leadership on evidence quality and portfolio trends.
• Provide strategic oversight of audits and regulatory inspections, including preparation and response.

Skills

TMF Operations

Inspection readiness

Regulatory inspections

GCP knowledge

Cross-functional leadership

Budget and resource planning

Stakeholder management

Change management

Effective communication

Education

Degree educated

Job description

DIRECTOR STUDY EVIDENCE AND READINESS

What you will do

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

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., 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.

careers.amgen.com