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Associate Director, Companion Diagnostics
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- Our shared mission is to unlock the power of gene therapy to accelerate healthcare transformation.
- In this role, the Associate Director Companion Diagnostics will serve as the Companion Diagnostic (CDx) subject matter expert responsible for driving CDx development programs required for patient selection strategies for Spark's gene therapy development teams, ensuring that the CDx deliverables align with the gene therapy development program milestones at critical junctures.
- Primary point of contact with CDx partner (day-to-day) to monitor assay development and validation activities, transfer progress, troubleshoot, communicate evolving needs to ensure timely implementation of CDx strategy.
- Lead the Spark CDx cross functional subteam(s) and the Dx partner-facing joint CDx Project Teams (with team management support from Program management) covering all areas from CDx assay development through CDx approval and launch.
- Be accountable for delivery of diagnostic partner critical milestones, including assay development, analytical validation, clinical validation, and regulatory activities.
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