Karen Doolittle

Short Biography

Strategic Operations Leader | Transformation, PMO & Change Leadership

Enterprise transformation and delivery leader with deep expertise in program and project management, strategic planning, and organizational change. Known for translating executive vision into scalable execution across complex, matrixed organizations by aligning diverse teams to drive collective problem-solving. Trusted partner to senior leaders, delivering revenue growth, cost optimization, and operational excellence through disciplined governance.

Core Competencies

Strategic Planning & Execution | Portfolio/Program/Project Management (PfMP, PgMP, PMP) Organizational Transformation | Change Management (Prosci) | Cross-Functional Collaboration
Executive Reporting & KPI Dashboards | Stakeholder Engagement | Vendor Oversight | Big4 Consulting Governance & Risk Mitigation | Agile, Scrum, Waterfall | Lean Six Sigma | Communication Skills
Tools: ChatGPT, Google Generative AI Leader, Jira, Smartsheet, SAP, CRM, Visio, Miro

Over the past two decades, I’ve led enterprise-wide transformations at industry leaders including Moderna, Amgen, Toyota, and EY—delivering digital acceleration, operational optimization, and regulatory readiness. At Moderna, I directed a global portfolio of 15+ programs across Clinical, Safety, Regulatory, and Commercial functions, achieving a 50% reduction in literature search time, a 230% increase in data quality, and deploying AI-powered safety tools that strengthened regulatory compliance. At Amgen, I drove quality-focused programs that halved processing times and boosted regulatory responsiveness by 80%.

I’ve also built and scaled PMOs from the ground up, delivering more than $1B in value through standardized governance, decision-making frameworks, and ROI-driven execution strategies. Known for fostering collaboration, clarity, and accountability, I empower teams and executives with actionable insights, inclusive leadership, and innovative approaches to complex challenges.