Medical Director of Digital Pathology
The Medical Director of Digital Pathology (MDDP) will be responsible for the design, implementation, and management of the Caris digital pathology operation. This will include development and validation of automated image analysis, artificial intelligence image analysis, and digital workflows in support of these goals. They will be responsible for managing an international group of pathologist contractors and managing regulatory and quality affairs associated with digital pathology sign-out. In addition, the MDDP will have expertise in Anatomic and Clinical Pathology and will review and sign out the high complexity tests offered by Caris Life Sciences, which includes surgical and molecular pathology testing.
- Design and manage digital pathology workflow.
- Manage group of contract Pathologists.
- Work with and provide direction to Caris Quality and Legal teams around digital pathology regulations and QA/QC.
- Work with Research & Development team to develop automated image analysis including artificial intelligence-based diagnosis and staining interpretation
- Conduct pathologic examination of submitted specimens.
- Evaluate adequacy of specimens for testing and make recommendations when limited specimen is available.
- Provide interpretation of immunohistochemical (IHC) stains.
- Provide interpretation of in-situ hybridization (ISH) stains.
- Review batch and instrument quality control stains as needed.
- Evaluate pathology specimens and render insightful and comprehensive diagnoses to enable clinicians to best treat their patients.
- Review all elements of a tumor profiling and sign-out the report.
- Consult with peer Oncologic Pathologists on cases as requested or needed.
- Participate in Quality Assurance programs, i.e., serve as reviewer for cases and participate in intradepartmental conferences to ensure and improve accuracy of diagnoses and quality of care.
- May train and supervise pathology assistants, residents and fellows engaged in specialty training.
- Follow established policies, procedures, and objectives, continuous quality improvement objectives, safety, environmental, and/or control standards.
- Promote and work to improve relationships with clinicians and the pathology community.
- Assist with projects from Pharma Services.
- Assist as needed to perform other related duties and special projects as required.
- CLIA/NYS/CAP/ISO 15189 2012:
Each individual performs only those high complexity tests that are authorized by the laboratory director and require a degree of skill commensurate with the individual’s education, training or experience, and technical abilities.
Each individual performing high complexity testing must:
- Follow the laboratory’s procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results;
- Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens;
- Adhere to the laboratory’s quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed;
- Follow the laboratory’s established policies and procedures whenever test systems are not within the laboratory’s established acceptable levels of performance;
- Be capable of identifying problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the general supervisor, technical supervisor, clinical consultant, or director;
- Document all corrective actions taken when test systems deviate from the laboratory’s established performance specifications; and
- Perform high complexity testing under the onsite, direct supervision of a general supervisor as defined in the CLIA regulations.
The general supervisor must be accessible to testing personnel at all times testing is performed to provide on-site, telephone or electronic consultation to resolve technical problems in accordance with policies and procedures established either by the laboratory director or technical supervisor. The general supervisor is responsible for providing day-to-day supervision of high complexity test performance and is responsible for monitoring test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained.
The following responsibilities may be delegated to the Oncologic Pathologist:
- Assuring that all remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications;
- Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is properly functioning;
- Providing orientation and training to all testing personnel, staff engaged in the performance of supportive tasks such as data entry, accessioning and reporting, as well as supervisory and management staff.
- Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently.
- Participation in a proficiency testing program commensurate with the services offered.
- In the selection of laboratory equipment and supplies.
- Knowledge, Skills, and Experience
- Ability to learn internal software programs for diagnosis purposes.
- Proven ability to learn and collaborate with others in a complex, multi-functional and specialty environment.
- Knowledge and experience using diagnosis equipment (microscope, Dictaphone, computer).
- Ability to communicate effectively (gross descriptions).
- Requires a high degree of care and attention with strict adherence to defined clinical testing protocols.
- Demonstrated skills and high level of attention to detail in technical data interpretation and ability to troubleshoot.
- Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use.
- Ability to multi-task and work in a fast-paced, deadline driven environment.
- Drive for Results (Service, Quality, and Continuous Improvement) – Ensure procedures and processes are in place that lead to delivery of quality results and continually reassess their effectiveness to achieve continuous improvement.
- Communication – Proficient verbal and written communication skills. Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results.
- Teamwork – Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team.
- Customer Service Focus – Demonstrate a focus on listening to and understanding client/customer needs and then delighting the client/customer by exceeding service and quality expectations.
- Education, Certification/Licensure, and/or Experience
- The Oncologic Pathologist must be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology.
- Be licensed in the state for which interpretations are performed.
- Physical Demands
- Will work at a computer some of the time as well as need to keep inventory and ordering records requiring the use of copiers, fax machines, and PDF scanners.
- Visual acuity and analytical skill to distinguish fine detail.
- Manual dexterity to use common laboratory equipment and perform sterile techniques as required.
- Must possess ability to sit and/or stand for long periods of time.
- Must possess ability to perform repetitive motion.
- Ability to lift up to 5 pounds.
- May have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment. Exposure to formaldehyde, xylene, DAB and alcohol which emit fumes. The formaldehyde, xylene, and DAB are carcinogenic.
- May be required to handle blood-borne pathogens and general laboratory reagents.
- Required Training
- All job specific, safety, and compliance training are assigned based on the job functions associated with this position
- This position requires periodic travel and some evenings, weekends and/or Holidays.
- This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.