Teams at Nanopath

Lead the planning, startup, execution, and oversight of multi-site clinical studies supporting FDA clearance of diagnostic products. Responsibilities include IRB submissions, site selection and monitoring, clinical documentation, vendor coordination, milestone tracking, risk management, regulatory materials, and stakeholder updates. The role requires strong GCP and ICH knowledge, experience with diagnostic or medical device trials, and collaboration with CROs, central laboratories, and research sites.

Develop, optimize, and scale assay and reagent workflows for a diagnostics platform. Create robust protocols for reagent manufacturing, array fabrication, and assay execution. Support process characterization, QC, stability, and verification studies. Prepare reagents and maintain lab operations, collect and analyze data, troubleshoot experiments, and collaborate cross-functionally to implement improvements toward regulated product development.

Lead the electrical design and development for Nanopath's diagnostic platform, focusing on system architecture, PCB design, and integration. Collaborate with cross-functional teams to ensure effective system performance and compliance with medical standards.