Medical Director (CAP/CLIA Laboratory)

Roche•Tucson, AZ

12d

About The Position

Roche is seeking an experienced Medical Director to oversee regulatory compliance, quality, and medical interpretation for its CAP/CLIA-accredited Roche Tissue Diagnostics Laboratory. The role serves as the CLIA and State of Arizona Laboratory Director for the Tucson and Penzberg laboratories, with medical and scientific oversight of high-complexity histopathology testing, including single-plex IHC, multiplex immunofluorescence (mIF), chromogenic multiplex IHC, and in situ hybridization (ISH/FISH). The Director oversees analytical assay validation, quality assurance and quality control, proficiency testing, and digital pathology and image-analysis assay validation, while maintaining inspection readiness for CAP, CLIA, Arizona, NYS CLEP, and client audits. The position provides strategic quality and technical alignment across laboratory operations in Tucson, Arizona, and Penzberg, Germany. It interprets prospective and retrospective clinical-trial samples, including deriving H-scores, cell-density metrics, and spatial signatures to support diagnostic interpretation algorithms and companion diagnostic development. The role ensures adherence to GCLP, GCP, 21 CFR Part 11, and FDA biomarker-development guidelines, and supports exploratory and pivotal biopharma clinical trials from Phase I through Phase III. International travel to Penzberg, Germany, is required up to twice a year.

Requirements

M.D. or D.O. with specialized training in Pathology.
Board certification in Anatomic Pathology or Anatomic & Clinical Pathology by the American Board of Pathology or American Osteopathic Board of Pathology.
Hold or be eligible for an active, unrestricted Arizona physician license and meet ADHS Clinical Laboratory Director qualification criteria.
Hold or be eligible to obtain a New York State Certificate of Qualification in Histopathology and related subspecialties upon hire.
Meet 42 CFR 493.1443 requirements for 20 continuing education credits in CLIA Laboratory Directorship responsibilities, or an equivalent board-certified track.
At least 5 years directing or supervising high-complexity testing in a CAP/CLIA-accredited clinical environment or biopharma central laboratory.
Deep subject-matter expertise in IHC development, multiplex assay design (mIHC/mIF), spatial transcriptomics/biology, and quantitative digital image analysis.
Working knowledge of GCLP/GCP guidelines, 21 CFR Part 11, FDA Companion Diagnostic frameworks, and CAP Anatomic Pathology checklist requirements.
Demonstrated ability to lead multidisciplinary teams and manage client-facing biopharma study deliverables.
Ability and willingness to travel internationally to Penzberg, Germany, up to twice a year.

Nice To Haves

Hands-on proficiency with AI-driven image-analysis software platforms such as HALO, Visiopharm, Definiens, or Roche digital pathology suites.
Experience developing and validating machine-learning algorithms or algorithm-assisted scoring methods for diagnostic application.
Track record of managing cross-border operational or regulatory workflows between U.S. and European operations.

Responsibilities

Serve as the named Laboratory Director under CLIA regulations, CAP accreditation standards, and Arizona Department of Health Services laboratory licensing laws for the Tucson and Penzberg laboratories.
Provide medical and scientific oversight for high-complexity histopathology testing, including single-plex IHC, multiplex immunofluorescence, chromogenic multiplex IHC, and ISH/FISH.
Oversee analytical validation protocols, QA/QC frameworks, proficiency testing, and digital pathology and image-analysis assay validation.
Maintain inspection readiness for CAP, CLIA, State of Arizona, NYS CLEP, and biopharma client quality audits.
Provide strategic quality and technical alignment across laboratory operations in Tucson and Penzberg.
Interpret prospective and retrospective trial samples, deriving H-scores, cell-density metrics, and spatial signatures to support diagnostic interpretation algorithms and companion diagnostic pipeline development.
Ensure end-to-end adherence to GCLP, GCP, 21 CFR Part 11, and FDA biomarker-development guidelines.
Lead multidisciplinary teams and manage client-facing biopharma study deliverables.
Travel internationally to Penzberg, Germany, up to twice a year.