Medical Director (CAP/CLIA Laboratory)
Roche
Summary
We are seeking an experienced Medical Director to direct regulatory compliance, overall quality, and medical interpretation for our CAP/CLIA-accredited clinical laboratory at Roche Tissue Diagnostics Laboratory. In this role, you will serve as the CLIA / State of Arizona Laboratory Director—ensuring full regulatory compliance—while leading a specialized pathology team focused on Immunohistochemistry (IHC), multiplex tissue profiling (mIHC/mIF), Cobas immunoassays and spatial biology supporting exploratory and pivotal biopharma clinical trials (Phase I–III). You will bridge high-complexity histopathology compliance with advanced tissue biomarker discovery, overseeing analytical assay validation, digital image analysis, and trial sample execution for global biopharma partners.
Job description
The Opportunity
CLIA/CAP & Arizona State Medical Directorship
- 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.
Cross-Site & Clinical Trial Strategy
- 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.
Who You Are
- 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.
Preferred Experience
- 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.
Requirements
- M.D. or D.O. with specialized training in Pathology
- Board Certified in Anatomic Pathology (AP) or Anatomic & Clinical Pathology (AP/CP) by ABP or American Osteopathic Board of Pathology
- Active, unrestricted Arizona Physician License or eligibility
- Fulfill ADHS Clinical Laboratory Director qualification criteria
- New York State Certificate of Qualification (CQ) in Histopathology or eligibility upon hire
- 42 CFR 493.1443 requirements of 20 CEs in CLIA Laboratory Directorship responsibilities or equivalent board-certified track
- 5+ years directing or supervising high-complexity testing within a CAP/CLIA-accredited clinical environment or biopharma central lab
- 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 (CDx) frameworks, and CAP Anatomic Pathology checklist requirements
- Proven track record leading multidisciplinary teams and managing client-facing biopharma study deliverables
- Able and willing to travel internationally up to 2 times a year to Penzberg, Germany
Benefits
- Relocation benefits
- Discretionary annual bonus
Company overview
Roche is a Swiss multinational healthcare company and a global pioneer in pharmaceuticals and diagnostics, founded in 1896 and headquartered in Basel, Switzerland. As the world's largest biotech company and the fifth-largest pharmaceutical company by revenue, Roche operates through two primary divisions: Pharmaceuticals and Diagnostics. The company is renowned for its leadership in personalized healthcare, combining strengths in both drug development and diagnostic testing to deliver tailored treatments for patients. Roche maintains a strong focus on oncology, immunology, infectious diseases, ophthalmology, and central nervous system disorders, with a portfolio that includes over 30 medicines on the World Health Organization's Model Lists of Essential Medicines. The company owns significant subsidiaries including Genentech, Chugai Pharmaceuticals, Ventana Medical Systems, and Foundation Medicine. With approximately 103,000 employees worldwide and operations in over 100 countries, Roche has established itself as a leader in cancer treatments globally while maintaining a robust pipeline of innovative therapies and diagnostic solutions. The company's commitment to sustainability has been recognized through ten consecutive years as Group Leader in the Dow Jones Sustainability Indices within the Pharmaceuticals, Biotechnology & Life Sciences Industry.