Teams at Agilent Technologies

Directs pathology services for companion diagnostic development, including team workload, pathology workflows, tissue sample review, scoring algorithms, digital pathology strategy, clinical trial support, and collaboration with Clinical, R&D, Regulatory, QA, and biopharma partners. Oversees consultant pathologists, assay development guidance, IRB/IEC study approvals, and pathology contributions to product launches and growth initiatives.

Leads the Companion Diagnostics design quality function and team, overseeing design controls, risk management, verification and validation, clinical performance evaluation, QMS processes, audits, regulatory compliance, investigations, and quality initiatives. Coordinates cross-functional development programs, partner collaborations, resources, budgets, and milestones while ensuring IVD and medical device products meet global regulatory and business requirements. Provides coaching, training, regulatory expertise, and people leadership across CDx development activities.

The Regulatory Expert will lead regulatory strategies for digital pathology products, engaging with teams and regulatory bodies to ensure compliance and mitigate risks throughout the product lifecycle.