Job Description

Career Category ClinicalHOW MIGHT YOU DEFY IMAGINATION?At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared missionxe2x80x94to serve patientsxe2x80x94has driven our status as one of the worldxe2x80x99s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.DEVELOPMENT TRANSFORMATION LEAD DIRECTORLIVEWhat you will doIn this vital role you will drive the process documentation transformation for end-to-end clinical trial execution by developing and implementing a modern framework that aligns with regulatory standards and industry best practices.This is a high-impact role critical to ensuring regulatory inspection readiness and effective adoption of new ways of working across the organization.Key Responsibilities:

• Collaborate cross-functionally with stakeholders across Clinical Development, Clinical Operations, Quality, Transformation, and Training/Knowledge Management teams as well as oversee external partners to ensure SOPs, training materials, and guidance documents are optimized for usability and compliance
• Collaborate with clinical experts to identify operational needs and shape documentation strategies
• Oversee external vendors delivering technical writing, process mapping, and change management support, ensuring outputs are aligned with strategic goals and delivered on time
• Drive change impact analysis and mapping by balancing current vs. future-state taxonomies for new and transitioning trials
• Support operational excellence through documentation that drives understanding and behavior change
• Drive xe2x80x9cblank sheetxe2x80x9d and holistic thinking to design user-friendly, future-state documentation and processes that are user-centric, intuitive, and connected across functions
• Sustain process documentation effectiveness through lifecycle management, reviews, and performance metrics

WINWhat we expect of youWe 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
• Experience in clinical development, operations, or clinical quality assurance within pharmaceutical, biotech, or CRO environments
• Experience leading large-scale process transformation and change management in a regulated (GxP) environment, and understanding of controlled document management frameworks, strategies and inspection readiness principles
• Ability to lead cross-functional initiatives, manage complexity, and influence across a matrixed organization
• Previous vendor operational oversight and work with external experts
• Strong strategic and analytical problem solver with proven ability to build frameworks in ambiguous environments and effective communication skills

THRIVEWhat you can expect of usAs we work to develop treatments that take care of others, so we work to care for our teammatesxe2x80x99 professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

LOCATION: Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.Application close date 16th May 2025APPLY NOWfor a career that defies imaginationIn our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.comEqual Opportunity StatementAmgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation..

Amgen