Senior Director, Companion Diagnostics

📋 Description

• Lead and mentor CDx teams to ensure compliant, high-quality data.
• Guide assay development, validation, and troubleshooting for cell therapy CDx programs.
• Ensure regulatory compliance with FDA guidance, ISO 13485/15189, CLIA/CLSI.
• Main client contact for scientific updates and expectations.
• Improve operations by reviewing SOPs and processes.
• Oversee audits, cross-functional coordination, and timely delivery.

🎯 Requirements

• PhD in Immunology or related field.
• 8+ years relevant experience (>=4 in industry).
• 5+ years leadership experience.
• Prior supervisory experience.
• Expertise in CDx for Cell Therapy and related regulations.
• Direct experience with cell-based assays for regulated studies.
• Solid understanding of GLP, GCP or GCLP standards.
• Working knowledge of CAP/CLIA, CLSI, ISO 13485.

🎁 Benefits

• Discretionary annual bonus.
• Health insurance.
• Retirement savings benefits.
• Life insurance and disability benefits.
• Parental leave.
• Paid time off for sick leave and vacation.