Director, Clinical Biomarkers Lab Head

What you will do

• 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 laboratorys technical director and primary pathologist, accountable for scientific strategy, operational excellence, compliance, and the integrity of clinical sample testing
• The position would report into US-based, PMED management.
• In this vital role you will successfully partner with cross-functional stakeholders to drive implementation of biomarker and diagnostics assay development
• The Clinical Biomarker Lab Head will be accountable for establishing a GCLP compliant clinical testing lab with immunohistochemistry, genomics and immunoassay capabilities.
• The Clinical Biomarker Lab Head will be accountable for execution of fit-for-purpose design, analytical validation, ongoing QC/QA monitoring, and timely revalidation/change control of biomarker assays.
• The Clinical Biomarker Lab Head will 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.
• The Clinical Biomarker Lab Head will provide expertise in human disease pathology and experimental pathology for development and interpretation of tissue-based assays.
• The Clinical Biomarker Lab Head will be accountable for turnaround time (TAT), throughput, first-pass yield, capacity planning, and business continuity/disaster recovery for IHC/genomics/immunoassay workflows.
• The Clinical Biomarker Lab Head will be accountable for competency assessment, ongoing training, and performance of lab personnel; safe practices and incident reduction.
• The Clinical Biomarker Lab Head will be accountable for establishing and following guidelines for compliance, audit-readiness, adherence to data integrity guidelines and implementation of corrective and preventive action plans.
• The Clinical Biomarker Lab Head is expected to mentor and nurture talent and create growth opportunities for staff members.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Highly experienced pathologist (MD or DVM degree) with 12+ years of relevant postdoctoral academic, clinical and/or industry pathology experience. PhD in addition to professional degree is a plus but not a requirement. Board certification in the United States is desirable but not required.

Worked in GCLP labs

• 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.