Medical Director (CAP/CLIA Laboratory)

Roche • Tucson, AZ

14d • $208,000 - $386,200

About The Position

Roche is seeking an experienced Medical Director for its CAP/CLIA-accredited Roche Tissue Diagnostics Laboratory. The role directs regulatory compliance, overall quality, and medical interpretation, and serves as the CLIA and State of Arizona Laboratory Director. It oversees specialized pathology work supporting exploratory and pivotal Phase I–III biopharma clinical trials, including immunohistochemistry (IHC), multiplex tissue profiling (mIHC/mIF), Cobas immunoassays, and spatial biology. The position bridges high-complexity histopathology compliance with tissue biomarker discovery, overseeing analytical assay validation, digital image analysis, and clinical-trial sample execution for global biopharma partners.

The Medical Director provides medical and scientific oversight of high-complexity histopathology testing and regulatory compliance for laboratories in Tucson, Arizona, and Penzberg, Germany. The role aligns quality and technical practices across sites, supports interpretation of clinical-trial samples and companion diagnostic development, and maintains readiness for regulatory inspections and client audits.

Requirements

• M.D. or D.O. with specialized training in Pathology.
• Board certification in Anatomic Pathology (AP) or Anatomic & Clinical Pathology (AP/CP) by the American Board of Pathology or American Osteopathic Board of Pathology.
• Active, unrestricted Arizona Physician License, or eligibility to obtain one, and fulfillment of Arizona Department of Health Services 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.
• Fulfillment of 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 within a CAP/CLIA-accredited clinical environment or biopharma central laboratory.
• Deep 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.
• A track record leading multidisciplinary teams of pathologists, laboratory technicians, and bioinformaticians, and managing client-facing biopharma study deliverables.
• Ability and willingness to travel internationally up to twice a year to Penzberg, Germany.

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 managing cross-border operational or regulatory workflows between US 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 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, and digital pathology/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 operational units in Tucson, Arizona, 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 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.

Benefits

• Discretionary annual bonus may be available based on individual and Company performance.
• Benefits are available as detailed at the provided benefits link.
• Relocation benefits are available.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree