Compliance

• Lead global regulatory strategy for biomarkers and diagnostics.
• Focus on early-stage development through proof of concept and supporting registrations.
• Establish scalable frameworks for investigational assay development, ensuring timely, compliant submissions that support patient stratification in Phase I/II studies.
• Serve as the regulatory lead on the Translational Medicine CLIA Laboratory Steering Committee.
• Champion innovative regulatory strategies to resolve complex challenges and accelerate patient access.
• Cultivate inclusive, high-impact collaboration with Precision Medicine, Research teams, Global and Regional Regulatory Leads, Global Regulatory Operations, and Quality.
• Oversee global precision medicine submissions and health authority interactions including PSAs, SRD, Pre-subs, IDEs, and international submissions.
• Provide regulatory support on product partnership, vendor management, and business development opportunities.
• Act as a strategic regulatory thought leader by shaping policy through trade association engagement and maintaining awareness of scientific, competitive, and diagnostic industry trends.

Director, Early Precision Medicine Regulatory Affairs

Director, Ethics and Compliance Investigations

Regulatory Engineer

Executive Director, Regulatory Science & Strategy – Oncology

Director, Global Regulatory Leader

Director, Global Regulatory Leader