Teams at Foundation Medicine

Lead establishment of FMI's internal device manufacturing for IVD reagents and kits: build team, implement GMP/GDP-compliant QMS (21 CFR Part 820, ISO 13485), develop SOPs and batch records, oversee production scheduling and yield optimization, set KPIs and analytics (Python, Power BI), and drive regulatory readiness and cross-functional alignment for commercial supply.

Support and lead global product strategy and lifecycle for assigned diagnostic products: gather customer insights, define messaging, drive launches, forecast demand, analyze market and competitive trends, liaise with commercial, clinical, finance, and project teams, and provide on-market support and stakeholder engagement.

Develop and apply algorithms on multimodal datasets (genomics, clinical outcomes, imaging) to discover biomarkers and therapeutic targets. Lead statistical investigations of oncogenesis, prognostic/predictive markers, drug resistance, and disease monitoring. Manage codebases and dataset versioning, collaborate with clinical partners on translational research and publications, represent the team to cross-functional stakeholders, and communicate complex results to technical and non-technical audiences.