Director, Clinical Pathology

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At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.

Position Overview

The Director, Clinical Pathology serves as a surgical pathology expert in the daily operations of the Clinical Laboratory, acting as a critical bridge between pre-analytic surgical pathology and post-analytic molecular testing results by reviewing tissue sent in for commercial assays, providing medical expertise in the assessment of patient materials, identifying process improvement opportunities, supporting physicians regarding patient results and laboratory processes, training Pathology staff, and generating and reviewing Pathology Quality Management analytics. The individual in this role collaborates with Histology, Molecular Laboratory, Quality Control, Quality Assurance, Systems Engineering, Information Technology and Medical Software in the improvement and development of new processes and technologies to ensure the quality and timeliness with which patient samples are processed. This position plays a key role in assisting with internal and external inspections. The Director also provides critical content expertise to cross-functional teams to launch new pathology laboratory processes and systems, develop global pathology support for new products and services, and support post-market studies.

Essential Duties

Include, but are not limited to, the following:

• Lead and manage the Pathology team in support of daily operations and communication ensuring high quality and timely processing. This includes oversight of daily scheduling for all clinical laboratory pathology reads, e.g., initial H+E reads, QC reads, report sign out.
• Contribute to management of our growing business by analyzing pathology costs, budgeting, troubleshooting technical and non-technical problems, coaching and mentoring staff, building effective teams, managing projects and taking accountability for pathology operations.  
• Ensure that policies and procedures are established and followed for monitoring individuals who conduct any pathology phase of testing (pre-analytic, analytic or post-analytic), to assure they are competent and maintain their competency, and to identify needs for remedial training and continuing education to improve skills.
• Lead Pathology training for both on-boarding and ongoing education/competency assessment
• Act as Pathology services subject matter expert representative for internal laboratory teams.
• Act as a critical resource for complex H&E and IHC review and sample management and perform expert microscopic review of clinical laboratory H&E and IHC slides.
• Lead and/or participate in Clinical Pathology process improvements to ensure pathology methodologies have the capability of providing quality results required for patient care.
• Oversee testing and integration of new technologies into the pathology workflow, including new digital pathology systems and integration of artificial intelligence.
• Partner with the Laboratory Director to ensure high quality and efficient sample management and operations to maximize molecular output quality for validated tests.
• Develop professional relationships with and provide consultative service to key internal stakeholders and collaborators including Customer Service, Medical, Molecular Laboratory, Biorepository, Quality Assurance, Quality Control, Service Engineering, Process Engineering, Information Technology, and Medical Software.
• Provide expertise in tissue review and serve as a resource for the development, writing, and review of study concept sheets, study protocols, abstracts, and manuscripts.
• Collaborate with cross-functional partners on efforts during new product commercial launches, such as on training Clinical Pathology staff and translating, standardizing, and documenting standard operating procedures (SOPs).
• For product launches, assist in defining and developing sample submission criteria and product materials, respond to customer service outreach calls, train staff for customer product queries, and scale customer call backs regarding all pathology-related questions.
• Provide support throughout post market product life cycle including training, assistance in sample submission process optimization, and trouble-shooting customer sample preparation issues.
• Review submitted pathology reports and materials.
• Review and publish molecular testing reports.
• As requested, provide input in the development of educational slide decks, sales materials, speaker events, Speaker Train