Department

Pathology Services Group

Position Title

Pathologist/Senior Pathologist

Reporting Line

Pathology Group Leader (or Chief Medical Officer)

Approved in Current Budget?

Yes

Exempt or Nonexempt?

Exempt

Salaried or Hourly?

Salaried

Position Summary

The Pathologist/Senior Pathologist (“Pathologist”) is a key member of CND’s growing Pathology Services Group which performs expert reading of immunofluorescent images of patient skin biopsies for the Company’s Syn-One Test^® (and other cutaneous assays) to help diagnose neurodegenerative diseases including Parkinson’s and dementia with Lewy bodies. The Pathologist brings a diverse set of experience analyzing patient tissue in clinical and/or academic settings and has familiarity with immunohistochemistry and/or immunofluorescent techniques. While not a requirement, the Pathologist may have specific experience in the field of neuropathology or dermatopathology and at a minimum is attracted to the field of neurodegeneration and novel pathological pathways that are emerging.

Given CND’s unique technology and pathological methods, the Pathologist is highly flexible, willing to learn new science and analytical processes, and driven by innovative ways to impact patient care. The Pathologist has a history of collaborating effectively with pathology department teammates and serving as an important expert resource for other colleagues including the laboratory technician team. The Pathologist is a consummate professional, has excellent attention to detail and quality, and considers herself/himself as a productive case reader. The Pathologist is also experienced with or highly interested in digital pathology methods and the use of AI-driven tools that may enhance overall reading capabilities for the organization. Additionally, the Pathologist has participated in research projects, has a keen eye for potential process improvements in the laboratory, and may enjoy participating in formal company-sponsored and/or industry clinical studies.

The Pathologist will be guided through an extensive, multi-week CND pathology training program to be “certified” to read and sign out cases for the company’s Syn-One Test^®, Small-Fiber Dx™, and other diagnostic products (which include multiple stains and biopsy samples per case).

Finally, the Pathologist has a strong academic background and a proven track record with recent employers, including spending multiple years at one or more clinical practices or private sector companies. The Pathologist is excited to join an early-stage, high-growth company and make key contributions to the company’s mission.

Job Responsibilities

Reading and Expert Interpretation for Commercial Testing

·       As a key member of a multidisciplinary anatomical pathology team, play an instrumental role in accepting and reading patient cases ordered by neurology, internal medicine, geriatrics, and other clinical practices around the US and internationally

·       Using immunofluorescence, and through the help of CND’s pathology assistance tool called NerValence, examine skin biopsies and analyze tissue samples to identify the presence of phosphorylated alpha-synuclein in dermal nerves while also measuring intraepidermal nerve fiber density and evaluating other cutaneous structures as part of the Syn-One Test, Small-Fiber Dx and other products

·       Achieve the required case concordance rates for the “Case Pair 1” neuropathology portion of the Syn-One Test by detecting phosphorylated alpha-synuclein (P-SYN) as well as measuring intraepidermal nerve fiber density (IENFD)

·       If the Pathologist has sufficient experience conducting dermatological analysis of tissue, including H&E and special stains, begin by becoming certified to read the “Case Pair 2” portion of CND’s Syn-One Test within the first weeks of starting the role

·       Input test results into the Company’s laboratory information management systems (LIMS) and ensure accuracy of data transfer

·       Collaborate closely with pathology team members on patient cases and support ongoing excellence in the reading capabilities of the department

·       Facilitate smooth and efficient reading processes with the prereading team and identify areas of ongoing quality improvement

·       Ensure reading protocols meet Company standards and are in compliance and alignment with standard billing practices

·       Increase reading productivity and efficiency over time while maintaining quality goals; review proficiency scores on an ongoing basis in collaboration with the Chief Pathologist, neurologist founders and other assigned resources on routine basis

·       Identify any patient specimens, cases, or slides that do not meet sufficient standards for analysis and follow Company standard operating procedures to resolve appropriately

·       In coordination with the Medical Affairs and Clinical Services teams, assist in responding to clinician inquiries related to pathology reports and test results

Reading for Research Studies and Industry Clinical Trials

·       Using the same pathology techniques applied in commercial testing, including the use of NerValence, when needed, play a key role in reading and interpreting slides of patient skin biopsy samples collected as part of clinical trials conducted by biopharmaceutical clients

·       Issue client specific pathology reports for patient participants

·       Offer expert interpretation of slides and provide additional analyses as dictated by each study protocol

·       Upon request, provide inputs into study design related to Syn-One and biomarker testing

·       Play an important role as a key part of each CND study team and interface with scientific members of the biopharma client when needed

Other Departmental Duties

·       Collaborate with members of the Pathology, Medical Affairs, R&D and other teams on a range of key initiatives consistent with the Company’s near and long-term objectives, including but not limited to:

o   ongoing quality program initiatives

o   the development and improvement of digital pathology and AI supported pathology reading (via the NerValence system)

o   the optimization of existing laboratory techniques and develop novel tests to aid in the diagnosis of neurodegenerative disease

o   the exploration of other cutaneous markers that may offer additional pathological insights on diseases of interest

·       Be accessible to the Laboratory Operations team for guidance on specimen processing and grossing, mounting, cutting and other laboratory techniques

·       Play an important ongoing role in suggesting improvements to the Company’s pathology workflows and the use of the LIMS

·       Attend Medical Executive Committee (MEC) meetings when requested and offer important points of view on medical policy, strategy, and other topics relevant to CND’s mission and day-to-day business

·       Over time, assist in the training and mentoring of new pathologists and prereaders upon request

Key Requirements

Knowledge, Skills & Experience

·       Minimum of 5-10 years as practicing pathologist either in private clinical setting or within the clinical/medical diagnostics industry

·       Background in anatomic/clinical pathology with possible specialty in neuropathology or dermatopathology

·       Extensive experience working in CLIA-certified and/or CAP-certified laboratories

·       Excellent communicator and collaborator with pathology teammates and other departments

·       Involvement with quality program design and implementation

·       Strong knowledge of imaging, quality control, and credentialing and accreditation

·       Strong knowledge of assay development/validations

·       Experience with equipment qualifications and laboratory design

·       Experience with biopharmaceutical industry projects a plus

·       Comfortable working within a LIMS system and using digital technologies as part of daily workflow

Education, Certifications, and Licensures

·       MD in anatomical pathology, clinical pathology, dermatopathology or neuropathology

·       Ph.D. a plus

·       Strong academic credentials from top residency and fellowship programs

·       Licensed in multiple states

Special Training

·       Validation and assay development

·       Will be guided through CND’s pathology training program to become certified to read cases for the Syn-One Test, Small-Fiber Dx, and other proprietary cutaneous neurodiagnostic tests; travel to CND’s Boston office required during training period

Location/Other

Work Location and Office Model

·       The Pathologist will be based in the greater Phoenix area and will spend the majority of the time working in an assigned office at CND’s 10,000 square foot headquarters and laboratory facility in Scottsdale, AZ

·       Potential to work in a hybrid working environment with some remote, home-based reading as the Company evolves its digital pathology capabilities (long term)

Physical Demands:

·       Combination of seated and standing work to complete the core functions of the role