Guardant HealthDirector, Clinical Diagnostics
Jan. 2022 - Jul. 2023Generated CDx and CTA proposals including budget, resources, timelines, and analytical validation and clinical validation strategies. Reviewed contracts. Provided regulatory and clinical trial design support to pharma partners to maximize data generation or support product portfolio. Served as clinical science SME and JSC/JPT member and clinical lead for global CDx programs from initial partner interactions to design transfer. Supported regulatory interactions including IDE submissions, pre-sub, sPMA interactive reviews, and 100-day meetings.