Medical Director (CAP/CLIA Laboratory)

Job description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. 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. 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. 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 Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants .