Head of Biomarker Operations, WCH

Role Summary

Head of Biomarker Operations, West Coast Hub (WCH) - a strategic and operational leadership role overseeing biomarker operations across the WCH therapeutic portfolio, guiding a team of Biomarker Operations Study Managers and ensuring high-quality biomarker and bioanalytical data for clinical development from early to late-stage programs, including registrational studies.

Responsibilities

• Build, lead, and mentor a high-performing team of Biomarker Operations Study Managers
• Define and drive the biomarker operations strategy for the WCH programs, ensuring alignment with goals and priorities
• Provide strategic input into biomarker and bioanalytical planning, execution, and resource allocation across multiple programs and studies
• Serve as the primary liaison between biomarker operations and WCH Clinical Operations, Data Management, Quality, and other key cross-functional leaders
• Champion integration of biomarker operations into clinical trial design and execution, ensuring seamless coordination across functions
• Represent biomarker operations in key WCH forums, program teams, and strategic planning discussions
• Establish and oversee best practices for biosample collection, processing, storage, and testing strategies tailored to protocol requirements
• Ensure robust vendor oversight and management of central and specialty labs to meet quality and timeline expectations
• Lead process improvement initiatives to enhance operational efficiency, data integrity, and compliance with GCP, GLP, and GCLP standards
• Ensure timely delivery of high-quality biomarker and bioanalytical data for registrational studies, consistent with plans and clinical protocols to support regulatory filings
• Partner with Quality and Compliance to uphold standards across biomarker operations, ensuring audit readiness and regulatory adherence
• Ensure biomarker data is delivered in a format and quality suitable for regulatory submissions and scientific publications
• Provide expert input into protocol development, informed consent forms (ICFs), and data management plans

Qualifications

• Bachelor’s degree in a biological science or related field with 15+ years of experience or advanced degree with 12+ years of experience
• Extensive industry experience in clinical biomarker operations, biomarker/bioanalytical sciences, clinical operations, or related disciplines
• Proven leadership experience managing teams and driving strategic initiatives in a matrixed, fast-paced clinical development environment
• Deep understanding of clinical trial operations across all phases, biomarker strategy, and specialty lab testing (PK, ADA, exploratory biomarkers)
• Experience with data integration and transfer processes between testing vendors and internal data systems
• Expertise in biomarker and bioanalytical assay platforms (flow cytometry, immunoassays, genomics, etc.)
• Familiarity with contracting processes, including Master Service Agreements and Statement of Work development
• Demonstrated success in cross-functional collaboration, vendor management, and GCP/GLP/GCLP compliance
• Experience supporting biomarker and/or bioanalytical operations for registrational studies and regulatory filings
• Exceptional organizational, communication, and stakeholder engagement skills

Skills

• Strategic biomarker operations planning
• Team leadership and people development
• Cross-functional collaboration and stakeholder management
• Vendor management and contract oversight
• GCP/GLP/GCLP compliance and quality assurance
• Data management and integration across systems
• Regulatory submissions preparation

Education

• Bachelor’s degree in biological sciences or related field; advanced degree preferred