Kelly A. Boyle is an accomplished Senior Clinical Program and CMC Project Management Leader with extensive experience in the biopharmaceutical industry, including leadership roles at Johnson & Johnson and Merck. She specializes in clinical and drug development programs, regulatory affairs, portfolio management, and strategic execution. With a strong foundation in chemistry and advanced project management, she has successfully led cross-functional teams, accelerated regulatory submissions, optimized resource planning, and improved operational efficiency. Her proven achievements include reducing TREMFYA submission timelines by 42%, improving forecasting accuracy to less than 5% variance, and increasing on-time program delivery by 25%. She is a results-driven leader committed to advancing drug development and delivering measurable organizational impact.
WORK HISTROY
Led cross-functional Clinical, Preclinical, CMC, Regulatory, and Commercial programs, improving on-time milestone delivery by 25% across complex development portfolios.
Accelerated TREMFYA regulatory submission timelines from 6 months to 3.5 months, strengthening program execution and supporting timely regulatory milestones.
Developed executive project management tools and resource planning frameworks, reducing planning cycle times by 35% and improving forecasting accuracy from over 20% variance to less than 5%.
Coordinated cross-functional planning across Clinical Development, Regulatory, CMC, and Global Clinical Supply, improving milestone delivery visibility by 20%.
Developed executive portfolio reports and schedule analytics, reducing reporting turnaround time by 25% and supporting informed management decisions.
Evaluated financial forecasts, resource allocation, and program risks while streamlining Planisware reporting processes, improving portfolio planning efficiency by 15% and reducing administrative planning time by 20%.
Led formulation development, GLP/GMP manufacturing, and CMC activities, advancing oral and parenteral products from preclinical research through Phase II.
Managed manufacturing operations and clinical supply planning, maintaining 100% regulatory compliance across critical drug development programs.
Authored over 50 technical reports and improved EMEND formulation stability to support room-temperature storage, reducing cold-chain complexity and associated supply costs.
STRATEGIC LEADERSHIP & ACHIEVEMENTS
CORE STRENGTHS
Clinical Program & Project Management
CMC & Drug Development Operations
Strategic Portfolio Management
Regulatory Affairs Coordination
Resource & Capacity Planning
Project Portfolio Governance
Risk Assessment & Mitigation
Cross-Functional Team Leadership
Executive Communication
Stakeholder Engagement
Operational Excellence
Strategic Planning & Execution
CAREER PHILOSOPHY
Kelly believes in combining strategic vision, disciplined execution, and collaborative leadership to achieve meaningful results. She focuses on optimizing resources, strengthening cross-functional partnerships, and improving processes to advance drug development, enhance organizational performance, and deliver lasting value across the biopharmaceutical industry.
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