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Work Background
CDx InSightIndependent Consultant
Jul. 2023Providing strategic and technical planning guidance for LDT, IVD and CDx development for pharmaceutical and biotech companies.
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.
MerckDirector, Companion Diagnostics
Jul. 2020 - Jan. 2022Managed cross-functional teams in development of diagnostic strategy. Advanced internal efforts to utilize ctDNA in clinical studies. Supported clinical development teams from early-stage clinical trial design to global CDx.
HTG Molecular DiagnosticsSenior Manager, Research & Product Development
Jul. 2019 - Jul. 2020Tucson, Arizona Managed direct reports and cross-functional product development teams, including CDx programs, for molecular profiling technologies. Drove product development standardization and best practices development. Oversaw product development documentation, customer communication, and participation in regulatory submissions.
HTG Molecular DiagnosticsManager, Product Development / CDx Development Lead
May. 2017 - Jun. 2019
Ventana Medical SystemsSenior Scientist & Technical Supervisor, Pharma Services
Mar. 2015 - May. 2017
Ventana Medical SystemsScientist, Pharma Services
Mar. 2012 - Mar. 2015
Arizona Cancer CenterGraduate Research Assistant
Aug. 2006 - Dec. 2011
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