Development Transformation Lead, Director - Remote

Overview

Join Amgen’s mission to serve patients by leading the transformation of documentation processes in clinical trials, ensuring compliance and operational excellence.

In Short

• Collaborate with cross-functional teams in Clinical Development and Operations.
• Oversee external partners for documentation development.
• Design and implement a documentation framework for clinical trials.
• Ensure regulatory compliance and inspection readiness.
• Lead process transformation strategies for clinical trial execution.
• Manage vendor relationships and operational oversight.
• Develop training materials and knowledge management systems.
• Facilitate change management and operational excellence initiatives.
• Measure documentation effectiveness and compliance.
• Drive strategic initiatives aligned with industry best practices.

Requirements

• Doctorate degree with 4 years of experience or Master’s with 7 years or Bachelor’s with 9 years relevant experience.
• 10+ years in clinical development or quality assurance.
• Experience in process transformation and change management.
• Strong knowledge of document management frameworks.
• Proven leadership in cross-functional initiatives.
• Excellent communication and stakeholder engagement skills.
• Familiarity with Quality Management System principles.
• Experience with digital platforms supporting clinical trials.
• Background in organizational transformation initiatives.
• Strategic and analytical thinking abilities.

Benefits

• Comprehensive employee benefits package.
• Retirement and savings plans with company contributions.
• Medical, dental, and vision coverage.
• Flexible work models including remote options.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Career development opportunities.
• Support for work/life balance.
• Inclusive environment fostering diversity and respect.