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Head of Companion Diagnostics & Regulatory Strategy

Precision Medicine Group

Precision Medicine Group in Frederick, MD seeks a Senior Director, Companion Diagnostics to oversee laboratory activities supporting both commercial CDx analyses and development programs. The role requires deep knowledge of FDA guidance and experience translating it into robust, pass-ready assays. You will lead design, validation, and CLSI/CLIA/CAP compliant operations, mentor staff, monitor KPIs, coordinate audits, and collaborate with QA, Regulatory and project teams to ensure timely client #J-18808-Ljbffr Precision Medicine Group

Vacancy posted 1 day ago
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