Career Category Clinical Job Description
HOW MIGHT YOU DEFY IMAGINATION?
At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s 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 DIRECTOR
LIVE
What you will do
In 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 “blank sheet” 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
WIN
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
* 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
THRIVE
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ 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 2025
APPLY NOW
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.com
Equal Opportunity Statement
Amgen 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.
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