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Biomarkers and diagnostics is central to understanding how our therapeutics work and identifying patients that benefit most from these therapies. Accordingly, the Precision Medicine (PMED) function plays a critical role in advancing our drug development programs and is accountable for the development of biomarker and diagnostics strategy across our pipeline. The PMED Center for Technology and Innovation group is responsible for implementing the biomarker and diagnostics strategies. We are seeking a highly motivated individual to provide pathology expertise and serve as head of a clinical testing laboratory with immunohistochemistry (IHC), genomics (e.g., NGS/qPCR), and immunoassay (e.g., ELISA/MSD) capabilities. The Lab Head will serve as the laboratory’s technical director and primary pathologist, accountable for scientific strategy, operational excellence, compliance, and the integrity of clinical sample testing.
Job Responsibility:
Accountable for establishing a GCLP compliant clinical testing lab with immunohistochemistry, genomics and immunoassay capabilities
Accountable for execution of fit-for-purpose design, analytical validation, ongoing QC/QA monitoring, and timely revalidation/change control of biomarker assays
Work closely with the computational imaging group to develop digital pathology/AI algorithms for IHC and/or H&E stained slides from clinical trial tissues across therapeutic areas
Provide expertise in human disease pathology and experimental pathology for development and interpretation of tissue-based assays
Accountable for turnaround time (TAT), throughput, first-pass yield, capacity planning, and business continuity/disaster recovery for IHC/genomics/immunoassay workflows
Accountable for competency assessment, ongoing training, and performance of lab personnel
safe practices and incident reduction
Accountable for establishing and following guidelines for compliance, audit-readiness, adherence to data integrity guidelines and implementation of corrective and preventive action plans
Mentor and nurture talent and create growth opportunities for staff members
Requirements:
Highly experienced pathologist (MD or DVM degree) with 12+ years of relevant postdoctoral academic, clinical and/or industry pathology experience
Worked in GCLP labs
Nice to have:
Familiarity with ISO 15189, 21 CFR Part 11/Annex 11, and digital pathology validation
A proven Molecular Pathology track record with credible publications and strong experimental Pathology supporting research
Demonstrated expertise in tissue-based analysis such as in situ hybridization, immunohistochemistry, fluorescence applications, laser capture microdissection
Expertise with image analysis software and algorithm design
Expertise in genomics
Expertise in immunoassays
Demonstrated excellence in independently leading and conducting research and ability to summarize information/data in a concise, easy to understand manner
Excellent leadership skills including mentoring, motivation and delegation
Excellent verbal and written communication and presentation skills
High level of initiative and ability to work independently
High level of business awareness
What we offer:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
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