The Position:

The Director, Laboratory and Pathology is accountable for the overall operation, administration, quality, and regulatory compliance of the South San Francisco laboratory, ensuring accurate, timely, and reliable laboratory services and appropriately qualified personnel. 

This is an onsite role based out of our South San Francisco, CA office with a schedule of Tuesday-Saturday. 

Responsibilities:

• Direct and oversee laboratory operations to provide high-quality, accurate, and timely diagnostic services. 
• Provide medical and scientific oversight of histology workflows, including tissue processing, embedding, microtomy, H&E staining, special stains, and immunohistochemistry. 
• Review H&E-stained slides; assess tissue adequacy, morphology, tumor content, and specimen quality for diagnostic and molecular testing. 
• Provide consultation on diagnostic interpretation, specimen triage, tissue handling, fixation, acceptance criteria, test utilization, and reported results. 
• Ensure compliance with applicable CLIA, CAP, NY state, and other regulatory requirements. 
• Participate in inspections and audits and ensure findings are addressed. 
• Oversee testing systems across pre-analytic, analytic, and post-analytic phases, including method selection, verification, validation, performance monitoring, and report content. 
• Ensure proficiency testing, quality control, quality assessment, and corrective action programs are established, maintained, reviewed, and documented. 
• Ensure personnel are appropriately qualified, trained, authorized, and competent, with responsibilities defined in writing and current procedures available. 
• Guide and mentor laboratory leaders and staff; delegate qualified responsibilities as appropriate while retaining accountability for their performance. 
• Monitor laboratory performance, turnaround time, workflow, budget, safety, environmental conditions, and reference laboratory selection. 
• Lead implementation of new technologies and process improvements, collaborate across disciplines, and remain accessible for onsite, telephone, or electronic consultation. 

Who You Are:

• A collaborative medical and scientific leader with strong clinical judgment and a commitment to patient-centered laboratory quality. 
• Skilled at leading, mentoring, and working effectively with pathologists, clinicians, laboratory personnel, and cross-functional partners. 
• Able to translate regulatory and quality requirements into clear, practical laboratory practices. 
• Able to maintain effective working relationships with applicable accrediting and regulatory agencies, administrative officials, and the medical community. 
• A clear communicator who can provide sound consultation, align stakeholders, and support timely decisions. 
• Analytical and improvement-oriented, with the ability to evaluate performance, identify risk, and advance efficient, reliable workflows. 
• Accountable, accessible, and adaptable in a changing clinical laboratory environment. 
• Able to travel to the San Diego office on a quarterly basis to attend business related meetings. 

Required Qualifications: 

• MD, DO, or DPM; licensed to practice in California; and certified in anatomic pathology by the American Board of Pathology or American Osteopathic Board of Pathology.  
• Fellowship in Molecular Pathology is required.  
• NY Certificate of Qualification in Oncology, Molecular and Cellular Tumor Markers required
• 10+ years of experience in a CAP/CLIA-accredited and/or New York State-licensed clinical laboratory. 
• This role is expected to work a Tuesday through Saturday schedule to support Laboratory Operations in South San Francisco, CA.   

The responsibilities above are representative and may include other duties consistent with the role and applicable regulatory requirements. 

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