Medical Director (CAP/CLIA Laboratory)

• Serve as the named Laboratory Director under CLIA regulations (42 CFR Part 493), CAP accreditation standards, and Arizona Department of Health Services (ADHS) laboratory licensing laws (A.R.S. Title 36) for both the Tucson and Penzberg laboratories.
• Provide overall medical and scientific oversight for high-complexity histopathology testing, including single-plex IHC, multiplex immunofluorescence (mIF), chromogenic multiplex IHC, and in situ hybridization (ISH/FISH).
• Oversee analytical validation protocols, QA/QC frameworks, proficiency testing (PT), and digital pathology/image analysis assay validation.
• Maintain continuous inspection readiness for CAP, CLIA, State of Arizona, NYS CLEP, and biopharma client quality audits.

• Provide strategic quality and technical alignment across operational units, including Tucson, AZ and Penzberg, Germany.
• Interpret prospective and retrospective trial samples - deriving H-scores, cell density metrics, and spatial signatures - to support diagnostic interpretation algorithms and companion diagnostic (CDx) pipeline development.
• Ensure end-to-end adherence to GCLP, GCP, 21 CFR Part 11, and FDA biomarker development guidelines.

• You are a M.D. or D.O. with specialized training in Pathology.
• You are Board Certified in Anatomic Pathology (AP) or Anatomic & Clinical Pathology (AP/CP) by the American Board of Pathology (ABP) or American Osteopathic Board of Pathology.
• You hold or be eligible for an active, unrestricted Arizona Physician License and fulfill all ADHS Clinical Laboratory Director qualification criteria.
• You hold or would be eligible to obtain a New York State Certificate of Qualification (CQ) in Histopathology (and related subspecialties) upon hire.
• You have fulfilled 42 CFR 493.1443 requirements of 20 CEs in CLIA Laboratory Directorship responsibilities (or equivalent board-certified track).
• You have 5+ years directing or supervising high-complexity testing within a CAP/CLIA-accredited clinical environment or biopharma central lab.
• You have deep subject matter expertise in IHC development, multiplex assay design (mIHC/mIF), spatial transcriptomics/biology, and quantitative digital image analysis.
• You have demonstrated working knowledge of GCLP/GCP guidelines, 21 CFR Part 11, FDA Companion Diagnostic (CDx) frameworks, and CAP Anatomic Pathology checklist requirements.
• You have a proven track record leading multidisciplinary teams (pathologists, lab technicians, bioinformaticians) and managing client-facing biopharma study deliverables.
• You are able and willing to travel internationally up to 2 times a year to Penzberg, Germany

• You have hands-on proficiency with AI-driven image analysis software platforms (e.g., HALO, Visiopharm, Definiens, or Roche digital pathology suites).
• You have experience developing and validating machine-learning algorithms or algorithm-assisted scoring methods for diagnostic application.
• You have a track record of successfully managing cross-border operational or regulatory workflows between US and European operations.

The expected salary range for this position based on the primary location of Tucson, AZ 208,000-386,200 USD annually. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

This position also qualifies for the benefits detailed at the link provided below. Benefits

Relocation benefits are available for this posting