Senior Director, Companion Diagnostics

Responsibilities

• Mentor and lead companion diagnostic teams to ensure high quality compliant data
• Direct staff to ensure consistent scientific standards and compliance with regulatory expectations
• Monitor and provide metrics and KPIs to senior leadership including quality metrics and revenue
• Manage client expectations and serve as the main scientific contact for projects
• Oversee assay development, validation, and troubleshooting for cell-based and non-cell-based assays
• Review and approve development and validation study protocols and reports
• Ensure laboratory operational excellence and compliance with ISO 13485, CLIA, and CLSI requirements

Requirements

• PhD in Immunology or a related field
• 18+ years of relevant scientific experience
• 12+ years of leadership experience
• Demonstrated expertise in Companion Diagnostics related to Cell & Gene Therapy
• Direct experience with cell-based assays used in regulated studies
• Working knowledge of CAP/CLIA, CLSI, and ISO 13485
• Solid understanding of GLP, GCP, or GCLP standards
• Proficiency in Microsoft Office Suite

Preferred Qualifications

• Direct experience working at a CRO, Biotechnology, or Pharmaceutical company
• Expertise in ELISA, MSD, Luminex, Quanterix, and SPR technologies

About the Company

Precision Medicine Group provides specialized services to support the development and commercialization of complex therapies.