Laura A. Hetman
Vernon Hills,IL
Summary
Strategic Senior Clinical Operations Leader with over 20 years of experience driving global drug development programs across multiple therapeutic areas. Proven track record in scaling clinical operations infrastructure, overseeing high-complexity Phase I–IV trials, and optimizing CRO and vendor management to ensure high-quality, inspection-ready delivery. Collaborative executive recognized for building high-performing cross-functional teams and integrating innovative operational strategies that accelerate timelines and maximize ROI.
Overview
33
33
years of professional experience
Work History
Senior Director, Clinical Operations
Tanabe Pharmaceuticals of America
Jersey City, NJ
10.2024 - Current
- Accelerated Rare Disease Portfolios: Drove end-to-end design and execution of early development clinical projects, bridging the gap from strategy to milestone delivery for high-priority assets.
- Regulatory Stewardship: Served as primary clinical operations lead for regulatory submissions, ensuring program objectives aligned with global compliance goals.
- Optimized Milestone Delivery: Championed the Clinical Operations Team Lead (COTL) role for all early-phase trials, consistently exceeding critical timelines through rigorous risk management.
- High-Impact Vendor Partnerships: Transformed CRO performance by implementing a strategic selection model and negotiating MSAs/SOWs that maximized budget efficiency.
Senior Director, Clinical Operations
Takeda
Cambridge, MA
03.2023 - 07.2024
- Global Trial Efficiency: Orchestrated a 20% increase in operational efficiency across global oncology trials by optimizing ICH-compliant workflows and cross-functional communication.
- Stakeholder Alignment: Acted as the primary bridge between internal stakeholders and strategic partners to ensure alignment on high-stakes oncology drug development.
- Process Innovation: Guided the design of standardized clinical operations processes, significantly reducing study start-up timelines and enhancing data quality.
Therapeutic Area Director / Director / Program Lead
AbbVie
North Chicago, IL
07.2016 - 03.2023
- Portfolio Acceleration (Eye Care & Specialty): Directed strategic delivery of portfolios, achieving all global milestones while institutionalizing risk-based monitoring for constant inspection readiness.
- Strategic Team Alignment: Scaled high-performing oncology teams by aligning asset goals with individual performance targets across early and late-stage development.
- Global Regulatory Transformation: Championed the global transition to new EU Clinical Trial Regulations, formulating a unified submission process that ensured zero disruption to timelines.
Associate Director / Program Manager / Senior Study Manager
Takeda Development Center Americas
Deerfield, IL
08.2004 - 04.2016
- Operational Modernization: Orchestrated large-scale transformations, including global EDMS integration and a multi-study corporate rebranding initiative.
- Award-Winning Excellence: Earned 8 performance excellence awards (Circle and Commitment) for delivering complex Phase I–III programs on schedule and under budget.
Senior Clinical Research Associate; Senior Associate Biochemist; Associate Biochemist
Abbott Laboratories
Abbott Park, IL
01.1993 - 01.2004
Education
Bachelor of Science (BS) - Biology
Bradley University
Peoria, ILSkills
- Clinical Leadership: Early Development & Phase II-IV Study Leadership, Clinical Site Management
- Operational Strategy: Global Trial Start-Up, Risk-Based Monitoring, Clinical Budget Forecasting
- Quality & Compliance: Inspection Readiness, Vendor Oversight, Regulatory Agency Interactions
- People Leadership: Mentorship, Talent Development, Building High-Performing Teams
Timeline
Senior Director, Clinical Operations
Tanabe Pharmaceuticals of America
10.2024 - Current
Senior Director, Clinical Operations
Takeda
03.2023 - 07.2024
Therapeutic Area Director / Director / Program Lead
AbbVie
07.2016 - 03.2023
Associate Director / Program Manager / Senior Study Manager
Takeda Development Center Americas
08.2004 - 04.2016
Senior Clinical Research Associate; Senior Associate Biochemist; Associate Biochemist
Abbott Laboratories
01.1993 - 01.2004
Bachelor of Science (BS) - Biology
Bradley University