Senior Director, Companion Diagnostics

Responsibilities

• Mentor and lead companion diagnostic teams to ensure high quality compliant data
• Oversee laboratory activities for commercially approved CDx sample analysis and development programs
• Direct staff to ensure scientific standards and compliance with regulatory expectations
• Monitor laboratory metrics including quality, TAT, assay failure rates, and revenue
• Manage client expectations and serve as the main scientific contact for projects
• Review and approve development and validation study protocols and reports
• Troubleshoot and correct scientific issues within the team
• Ensure compliance with ISO 13485, CLIA, and CLSI requirements

Requirements

• PhD in Immunology or a related field
• 18+ years of relevant professional experience
• 12+ years of leadership experience
• Demonstrated expertise in Companion Diagnostics related to Cell & Gene Therapy
• Direct experience with cell-based assays for 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 the life sciences industry, focusing on clinical development and commercialization strategies.