Senior Director, Companion Diagnostics

About the role

For our client, we are seeking a Senior Director Companion Diagnostics to join the team of a leader in the Pharmaceuticals & Biotech space. This role will lead technical work focused on cloud-enabled scalability, reliability, and delivery excellence. You will partner with business, technical, and operational stakeholders to build reporting, surface trends, and translate analysis into action. The position offers the opportunity to strengthen data-driven execution and help teams focus on the metrics that matter most within a life sciences environment.

Location: Frederick, MD – US based candidates only, no visa sponsorship available

Responsibilities

• Mentor and lead companion diagnostic teams to ensure compliance and data quality
• Identify and provide ongoing education to laboratory personnel
• Direct staff to uphold scientific standards and regulatory compliance
• Monitor metrics like quality metrics and assay failure rates for senior leadership
• Oversee laboratory inventory and ensure regular counts are performed
• Drive operational efficiency by reviewing processes and SOPs
• Act as the primary contact for clients regarding scientific project updates

Qualifications

• Ph.D. in Immunology or a related field
• 8+ years of relevant experience, with at least 4 years in industry
• 5 years of leadership experience
• Expertise in Companion Diagnostics with a focus on Cell & Gene Therapy
• Direct experience in cell-based assays for regulated studies
• Thorough understanding of GLP, GCP or GCLP standards
• Knowledge of regulatory requirements (CAP/CLIA, CLSI, ISO 13485)

Compensation

$203,200 – $304,800 annually

Benefits

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