Director, Study Evidence & Readiness

Amgen; United Kingdom; In loco; GBP 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

Amgen is seeking a Director of Study Evidence and Readiness to define strategy for TMF operations, drive inspection readiness, and partner with global teams to ensure regulatory compliance across the clinical portfolio.

You will lead and develop cross-functional teams, oversee audits, manage budgets and resources, push continuous improvement in TMF processes, and deliver strategic insights to senior leadership on evidence quality, risks, and study trends.

Competenze

• Life sciences or related field experience.
• Proven leadership of teams including management-level professionals.
• Expertise in TMF operations, inspection readiness, and regulatory inspections.
• Knowledge of global GCP requirements and trial documentation.
• Experience managing cross-functional projects within a matrix organization.
• Strong strategic leadership and stakeholder management.

Mansioni

• Define and execute the strategy for TMF Operations and Inspection Readiness.
• Lead, develop, and inspire global teams, driving performance and talent development.
• Oversee TMF quality and inspection readiness across the study portfolio.
• Manage resources, budgets, capacity planning, suppliers, training, and continuity.
• Drive continuous improvement of TMF processes, standards, SOPs, and systems.
• Partner with cross-functional stakeholders to resolve evidence issues and implement improvements.
• Establish performance metrics and provide strategic insights to senior leadership.
• Provide strategic oversight of audits and regulatory inspections and lessons learned.

Conoscenze

TMF Operations

Inspection readiness

Regulatory inspections

GCP knowledge

Leadership

Cross-functional leadership

Budget management

Stakeholder management

Formazione

Bachelor's degree

Descrizione del lavoro

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

• 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

• In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

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.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

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.