Development Transformation Lead, Director

Career Category

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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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.

Development Transformation Lead, Director

What you will do

Let’s do this. Let’s change the world. In this vital role you will collaborate cross-functionally with stakeholders across Clinical Development, Clinical Operations, Quality, Transformation, and Training/Knowledge Management teams, while also overseeing external partners that will develop the documentation. This is a high-impact role critical to ensuring regulatory inspection readiness and effective adoption of new ways of working across the organization.

We are seeking a strategic and experienced leader to drive the process documentation transformation for end-to-end clinical trial execution. This role will lead the strategy and implementation of a modern, fit-for-purpose documentation framework aligned with evolving regulatory expectations and industry best practices. A core focus is to optimize content is included in Standard Operating Procedures (SOPs), guidance documents, training materials, and knowledge management systems that incorporate industry best practices that enable compliance to GCP principles by enhancing usability for staff.

Responsibilities

Lead End-to-End Process Documentation Framework:

• Design and implement a comprehensive documentation framework for clinical trial processes, integrating changes from technology enablement and operating model updates.

Elevate a Controlled Document Strategy:

• Contribute to and implement R&D standards for document types including SOPs, work instructions, guidance documents and training content ensuring alignment with regulatory requirements and internal quality expectations with a focus on logical flows and linkages.

Liaison of Cross Functional Clinical Trial Processes:

• Solicit and identify operational dependencies impacting documentation design and implementation from deep clinical trial experts to shape process transformation strategies.

Oversee External Vendors and Consultants:

• Direct partner vendors providing technical writing, business process mapping, and change management support. Ensure outputs are aligned with strategic goals and delivered on time.

Enable Cross-Functional Process Alignment:

• Collaborate with business process owners (BPO), transformation leads, Quality and QMS teams, and learning and development partners to ensure documentation supports process clarity, compliance, and usability.

Drive Change Impact Analysis and Mapping:

• Lead the tracking and reconciliation between future-state and current-state process taxonomy. Develop and implement a systematic approach for tracking and mapping implementation of process changes on trials newly starting up or migrating to new processes

Enable Operational Excellence:

• Partner with training and change management leads to ensure new or updated documentation enables effective process understanding, critical thinking and behavior change that drive collectively own operational excellence across all roles.

Ensure Regulatory Compliance and Inspection Readiness:

• Ensure all documentation supports GxP compliance and inspection readiness. Maintain a high standard of quality, traceability, and audit ability.

Drive “Blank Sheet” and Holistic Thinking:

• Take a forward-thinking, “clean slate” approach to design future-state documentation and processes that are user-centric, intuitive, and connected across functions.

Sustain Process Documentation Effectiveness:

• Establish accountability structures for busi