Senior Director, Companion Diagnostics
Core
Overseeing laboratory activities for teams supporting commercially approved companion diagnostics (CDx) sample analysis and CDx programs in development, specifically for cell therapy assays.
Role type
Senior Director, Companion Diagnostics
Builds
Robust cell-based and non-cell-based assays for clinical and non-clinical studies
Domain
Cell & Gene Therapy / Companion Diagnostics / Regulated Bioanalysis
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA guidance knowledge, ISO 13485, ISO 15189, CLIA, CLSI validation, assay development, regulatory compliance, GxP/GLP/GCP/GCLP standards, cell-based assay execution, lab operations management, inventory management, SOP development, cross-functional coordination
Preferred skills
CRO/Biotech/Pharma experience, ELISA, MSD, Luminex, Quanterix, SPR technologies
Technologies
ELISA, MSD, Luminex, Quanterix, SPR
Responsibilities
Mentor and lead companion diagnostic teams to ensure high quality compliant data; Direct staff to ensure consistent scientific standards and regulatory compliance; Monitor and provide metrics (quality, TAT, failure rates) to senior leadership; Ensure lab efficiency and implement operational improvements; Act as main contact for clients regarding scientific updates; Participate in product development and life cycle management; Review and approve study protocols and reports; Oversee work execution and study compliance; Troubleshoot scientific issues; Prepare critical documents (protocols, reports, SOPs)
Seniority
Senior Director, strategic leadership & hands-on scientific oversight