Principal Associate Lab Director, PO Medical

Responsibilities

• Provide technical and scientific oversight for high-complexity molecular testing in a high-throughput commercial clinical laboratory.
• Lead the design, validation, verification, and implementation of new molecular assays and panels, including large-scale automation workflows.
• Establish and oversee comprehensive quality control and quality assurance programs, including bioinformatics quality metrics and pipeline monitoring.
• Ensure strict compliance with CLIA, CAP, and other applicable regulatory and accreditation requirements.
• Collaborate with operations leadership to optimize scalable workflows for sample accessioning, extraction, sequencing, and data analysis.
• Manage proficiency testing, investigate discordant results, and implement corrective actions.
• Mentor supervisors and senior technologists while providing technical escalation for complex molecular issues.

Requirements

• PhD, MD, or DO in molecular biology, genetics, pathology, or a closely related discipline.
• 5+ years of experience in high-complexity clinical molecular diagnostics, preferably in a high-throughput commercial environment.
• 3+ years of experience with laboratory automation, robotics, and high-volume workflow optimization.
• Demonstrated expertise in the validation and verification of molecular assays (e.g., PCR, NGS) and associated bioinformatics pipelines.
• Deep knowledge of CLIA high-complexity requirements and regulatory standards.
• Strong leadership skills with experience managing cross-functional technical teams.

Preferred Qualifications

• Board certification in a relevant discipline (e.g., ABMGG, ABP in Molecular Genetic Pathology, ABCC, or equivalent).
• 3+ years of experience managing CLIA inspections, audits, and proficiency testing programs.
• Professional certification such as MB(ASCP) or MLS(ASCP) with a molecular specialty.

Benefits

• Paid time off including vacation, holidays, volunteering, and personal time.
• Paid leave for parents and caregivers.
• Retirement savings plan.
• Comprehensive health benefits including medical, prescription drug, dental, and vision coverage.
• Wellness support.

About the Company

Exact Sciences is dedicated to helping change how the world prevents, detects, and guides treatment for cancer. We provide patients and clinicians with the clarity needed to make confident decisions through innovative molecular diagnostics.