Director, Study Evidence & Readiness

1027 Amgen Limited; Cambridgeshire and Peterborough; On-site; GBP 140,000 - 190,000; Full time

Benefits offered by this job

Competitive benefits

Total Rewards Plans

Job summary

Amgen Inc. is seeking a Director of Study Evidence and Readiness to shape the TMF Operations and ensure inspection readiness across global trials.

You will lead diverse teams, manage budgets and resources, and drive continuous improvement in TMF processes and documentation to meet regulatory standards.

Qualifications

• Degree in life sciences or related field.
• Strong knowledge of global GCP requirements and regulatory expectations.
• Experience leading TMF Operations in a matrix organisation.

Responsibilities

• Define and execute the strategy for TMF Operations and Inspection Readiness, aligning with clinical portfolio priorities and regulatory requirements.
• Lead, develop, and inspire global teams, driving performance and succession planning.
• Oversee TMF quality and inspection readiness across the study portfolio, identifying evidence gaps and driving remediation.
• Manage functional operations including resources, budgets, capacity planning, suppliers, training, and business continuity.
• Drive continuous improvement of TMF processes, SOPs, and systems to strengthen evidence quality and compliance.
• Partner with cross-functional stakeholders to resolve 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, ensuring preparation and effective response.

Skills

TMF Operations

Inspection Readiness

Regulatory Compliance

Cross-functional Leadership

Budget & Resource Management

GCP Knowledge

Strategic Thinking

Stakeholder Management

Education

Life sciences degree

Job description

DIRECTOR STUDY EVIDENCE AND READINESS

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

• 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

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.

About Amgen

Amgen is an independent biotechnology company that has helped pioneer the world of biotech in our fight against the world’s toughest diseases. 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.

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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

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.