Medical Director & Pathology Group Leader

The Medical Director and Pathology Group Leader (MD/PL) is responsible for overseeing the Company's CLIA-certified, CAP-accredited commercial laboratory while leading the pathology team's efforts to provide quality services for CND's neurodiagnostic testing business. The MD/PL is also expected to hold a Certificate of Qualification (CQ) for Histopathology - General in the state of NY or has eligibility to obtain such a certificate.

The ideal candidate brings a balance of medical expertise, team leadership, and strategic vision, fostering collaboration across multiple functions of the Company. The MD/PL is driven by patient-centric innovation, committed to high standards of care, and adept at leveraging cutting-edge tools such as digital pathology and AI. The MD/PL is a key member of CND's leadership team reporting to the Chief Medical Officer and plays an essential role in driving pathology excellence, laboratory quality, and exceptional service to clinician and patient customers of CND's cutaneous neurodiagnostic tests.

At CND, this role requires a split of activities. The first part is focused on serving as the Company's Medical Director of the commercial laboratory ensuring high quality standards, compliance with regulations, and a commitment to patient care and the second is focused on performing expert reading and interpretation of one or more assays within CND's cutaneous testing portfolio. The MD/PL brings a diverse set of pathology experience including familiarity with special stains, H&E, immunohistochemistry and/or immunofluorescent techniques. The MD/PL has served as the pathology team leader and/or medical director of a commercial laboratory or as part of a large health system and has deep interest in CND's mission to change the way neurodegenerative diseases are diagnosed and treated.

Given CND's unique technology and pathological methods, the MD/PL is highly flexible, willing to learn new science and analytical processes, and driven by innovative ways to impact patient care. The MD/PL 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 MD/PL is a consummate professional, has excellent attention to detail and quality, and considers themself as a productive case reader. The MD/PL also has experience with or is highly interested in digital pathology methods and the use of AI-driven tools that may enhance overall reading capabilities for the organization. Additionally, the MD/PL 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 MD/PL will become proficient at reading CND's innovative cutaneous neurodiagnostic tests. For the neuropathology portion of the Syn-One Test, the MD/PL will be guided through an extensive, multi-week CND pathology training program to be "certified" to read and sign out cases. As the leader of the pathology team, the MD/PL will play a key role in collaboration with Company founders to help design and implement a scalable onboarding and training program for all new pathologists and develop and maintain a competency scoring system for all team members. The MD/PL will also collaborate on a regular basis with many important departments including Pathology Operations, Medical Affairs, Regulatory Affairs and Quality Assurance, Laboratory Operations, R&D, and Clinical Services. The MD/PL forms close relationships with department leaders and other colleagues to foster a collaborative environment and serves as a mentor for key staff, leading by example with a strong work ethic and professionalism.

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

Job Responsibilities:

I. Medical Directorship and Laboratory Quality

Laboratory Leadership

• Serve as Medical Director for CND's CLIA-certified, CAP-accredited commercial laboratory in Scottsdale, ensuring compliance with regulatory standards (including CLEP certification for the State of NY)
• Collaborate with quality and laboratory operations teams to maintain accreditation readiness and laboratory excellence
• Oversee the development and maintenance of laboratory SOPs, quality measures, and proficiency testing programs
• Provide ongoing leadership, subject matter expertise, professional guidance, and ultimate authority for lab deliverables to customers
• Provide regular presence in the lab and make routine rounds throughout the facility, offering guidance to lab staff when needed in coordination with other lab operations personnel
• Be familiar with all disciplines and processes within the lab and serve as a liaison between the pathology team and lab operations personnel
• Be accessible to the lab staff to provide onsite, telephone or electronic consultation as needed as dictated by the hours of operation
• Develop and maintain an effective working relationship with lab operations management as well as other senior leaders including the Chief Medical Officer, Chief Scientific Officer, SVP, Operations, SVP, RAQA, and Quality Director
• Provide important inputs for ongoing enhancements to CND's LIMS
• Advise in the assessment and implementation of new processes, technologies and capital equipment
• Ensure the lab has sufficient qualified personnel with adequate documented training to meet workload demands
• Delegate the necessary authorities and hold people accountable for the documented tasks and deliverables
• Ensure that managers and supervisors have sufficient experience and expertise to lead their sections of the clinical lab

Quality & Regulatory

• In close collaboration with the SVP, RAQA, Laboratory Manager and Quality Team, review all new lab procedures and participate in the composition, review and approval of SOPs
• Establish quality evaluation methods, measures and protocols and review performance data prior to implementation of new processes
• Ensure that the lab monitors and evaluates the quality and appropriateness of services rendered within the context of the quality assurance program of the Company
• Assure quality of lab results by reviewing quality control, proficiency surveys and test data
• Attend important Quality meetings when needed and review the quality assurance/quality management report on a regular basis
• Ensure that the lab employs proficiency surveys for all analytes, thoroughly investigate discrepant results and document corrective action
• Periodically review patient results to determine that medically reliable data is being generated
• Promptly investigate lab errors and develop an action plan to prevent future occurrences
• Ensure that pathology and laboratory operations comply with all current accreditation and regulatory agencies such as AABB, CAP, CLIA, CLEP, FDA, JCAHO, and state authorities
• Ensure that the lab maintains a constant state of inspection readiness and is prepared for unannounced inspections by accrediting agencies

II. Pathology Reading and Pathologist Team Leadership

Pathology Reading

• Become proficient at reading CND's Syn-One Test and other cutaneous neurodiagnostics through successful completion of the Company's pathology training programs led by CND's neurologist founder
• If the MD/PL 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
• 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)
• Leverage CND's prereader resources and pathology assistance system (NerValence) to support the reading of Case Pair 1
• Upon successful completion of CNDs training programs, serve as a primary reader for the Syn-One Test and consult with CND's other pathologists on cases when necessary
• Help all pathologists achieve productivity rate goals; for Case Pair 1, attain the goal of 4 cases per hour or 25 cases per day within the first year of starting with the Company and 6 cases per hour or 35 cases per day by the end of the second year
• Become proficient at using the Company's LIMS system and work collaborative with Pathology Operations to complete cases with highest quality
• Provide accurate interpretation results and appropriate commentary on patient pathology report and communicate directly with ordering clinicians upon request from Medical Affairs and/or Clinical Services
• Upon conferring with Medical Affairs and/or Clinical Services, provide consultation to ordering clinicians in a timely manner regarding:
  • Investigation of discrepant or unexpected results
  • Inclusion of appropriate tests in clinical order sets and deletion of unnecessary tests
  • Requests for repeat tests
• Review all relevant patient information provided on each test requisition form to understand the clinical context of the patient and ordering clinician's needs; consult with CND's neurologists in Medical Affairs (or other founders) when discussion of any particular case is required
• Maintain constant, effective communication with the CMO and founders as well as pathology team members, the head of Quality, and other CND functional areas
• Bring key pathology/medical issues to the Company's Medical Executive Committee (MEC) on a weekly basis to discuss and resolve important matters

Pathology Department Leadership

• Lead the recruitment, onboarding, and management of CND's full-time, part-time, and contracted pathologists with support from HR, CND founders, and other resources
• Develop and maintain competency-based training programs for new and existing team members
• Establish productivity goals and monitor team performance, driving improvements in workflow and case throughput
• Promote a collaborative, high-performance culture aligned with CND's core values
• In collaboration with CND's neurologist founders, develop and implement training and education programs and serve as a mentor and capable coach for the pathology team
• Work effectively with the Pathology Operations Team to foster a collaborative environment, transparent and efficient workflow processes, and regular, professional communication. Ensure roles and responsibilities of the Pathology Operations Team are understood and respected by the Pathology Team
• Lead team meetings and one-on-one sessions that support ongoing growth of individual pathologists and the team as whole
• With the Pathology Operations Team and founders, conduct ongoing capacity planning and case assignment forecasts based on projected test volumes. Provide the necessary room for the Pathology Operations Team to coordinate the day-to-day case volume assignments and optimize pathologist throughput based on overall capacity plans established by the teams
• Communicate appropriate productivity goals for all team members by test (and relevant case pairs), review monthly team performance, and recommend course corrections when needed
• Lead by example and embody CND's values
• Keep the pathology team abreast of Company events and important information

Knowledge, Skills & Experience:

• 10+ years in pathology, including leadership roles in a clinical or commercial diagnostic setting.
• At least two years of experience supervising high complexity testing
• Experience in neuropathology or dermatopathology a plus
• Demonstrated expertise with immunohistochemistry, immunofluorescence, or similar diagnostic techniques.
• Proven track record of quality program development, laboratory operations, and compliance.
• Strong communicator with the ability to mentor and inspire diverse teams.
• Adept in digital pathology, LIMS systems, and AI-enhanced diagnostic tools.
• Commitment to innovation and a passion for advancing patient care.
• Minimum of 15-20 years as practicing pathologist either in private clinical setting or within the clinical/medical diagnostics industry and proven ability to build and lead a team of pathologists
• Background in anatomic/clinical pathology with possible specialty in neuropathology or dermatopathology
• Extensive experience working in CLIA-certified laboratory 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 (Ventana, Dako, and Leica Biosystems)
• Experience with biopharmaceutical industry projects a plus
• Comfortable working within a LIMS system and using digital technologies as part of daily workflow

Education, Certifications & Licensures:

• MD, DO, or DPM with board certification in anatomic pathology by the American Board of Pathology (ABP(AP)) or American Osteopathic Board of Pathology (AOBP(AP)); and
• Holds a Certificate of Qualification (CQ) for Histopathology - General in the state of NY (or eligibility to obtain); and
• Licensed in multiple states (or eligibility to obtain)
• Complete at least 20 CE credit hours in laboratory practice that cover director responsibilities as defined by the College of American Pathologists (CAP)
• Ph.D. a plus

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

Other:

• This position is based in CND's Scottsdale, AZ laboratory and headquarters.
• Combination of seated and standing work to complete the core functions of the role