Director, Study Evidence & Readiness

Amgen; Cambridge; Hybride; GBP 140 000 - 190 000; Plein temps

Résumé du poste

Amgen is seeking an experienced leader to head the global Study Evidence & Readiness function, shaping departmental strategy and overseeing TMF Operations and Inspection Readiness. You will ensure high-quality, compliant evidence across clinical studies and support regulatory readiness.

You will lead and develop global teams, manage budgets and resources, and drive continuous improvement of TMF processes. This role requires strong leadership, strategic thinking, and excellent stakeholder

Qualifications

• Experience in life sciences or related field (pharma/biotech/CRO).
• Proven leadership managing teams and professionals.
• Strong TMF Operations, inspection readiness, and regulatory inspections expertise.
• Knowledge of global GCP requirements and regulatory compliance.
• Experience managing cross-functional projects with budgets and resources.

Responsabilités

• Define and execute strategy for TMF Operations and Inspection Readiness aligned with regulatory requirements.
• Lead global teams, driving performance, development, and succession planning.
• Oversee TMF quality and inspection readiness across study portfolio and manage risks.
• Manage resources, budgets, capacity planning, vendors, training, and business continuity.
• Drive continuous improvement of TMF processes, standards, SOPs, and systems.

Connaissances

TMF Operations

Inspection readiness

Regulatory inspections

Vendor oversight

GCP knowledge

Strategic leadership

Formation

Degree educated in life sciences

Description du poste

Career Category

Clinical

Job Description

**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.

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 ex** pect 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.

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.

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