Director Clinical Operations

Heidi brings over 25 years of leadership in global clinical operations, with a proven track record in risk-based quality management (RBQM), centralized statistical monitoring (CSM), and cross-functional clinical trial execution across oncology, hematology, and immunology. She rejoins the clinical operations space after most recently serving as Director of Central Monitoring at Moderna, where she led global RBQM strategy, implemented enterprise-wide QTL frameworks, and advanced centralized monitoring to support regulatory readiness and clinical data integrity.

Earlier in her career at Celgene, Heidi helped build a global RBQM function from the ground up, mentored teams in Quality by Design (QbD), and led complex trials from early-phase development through registration. Her experience spans FDA, EMA, and PMDA inspection readiness, and she brings a thoughtful, systems-driven approach to operational excellence and patient-centered research.

Heidi’s scientific and operational roots include key roles at Aventis, Hoechst Marion Roussel, and the University of Kansas Medical Center. She holds a B.S. in Medical Technology from the University of Kansas, and is certified MT (ASCP), CCRA, and Lean Six Sigma Green Belt. She has also co-authored numerous publications in Blood, JCO, ASH, and EHA.

What makes Heidi’s return particularly special is her passion for this work—and for the people it serves. She brings not only a wealth of experience, but a deep commitment to advancing clinical programs that make a meaningful difference in the lives of patients.

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