Head of Biomarker Operations, WCH
About The Position
The Head of Biomarker Operations, West Coast Hub (WCH) is a strategic and operational leader responsible for driving the biomarker operations function across the WCH therapeutic portfolio. This role oversees a team of Biomarker Operations Study Managers and ensures the successful execution of biomarker and bioanalytical strategies that support clinical development from early to late-stage programs, including multiple registrational studies. Reporting directly to the Head of Biomarkers and Clinical Pharmacology, WCH, this role is a key interface with cross-functional stakeholders, including Clinical Biomarkers, Clinical Operations, Biometrics, Clinical Pharmacology, Regulatory, Quality and other internal and external partners. The successful candidate will bring deep operational expertise, scientific acumen, and leadership presence to ensure the delivery of high-quality biomarker and bioanalytical data that informs clinical development and regulatory strategy.
Requirements
- Bachelor's degree in a biological science or related technical field with 15+ years experience or advanced degree with 12+ years experience
- Extensive industry experience in clinical biomarker operations, biomarker/bioanalytical sciences, clinical operations, or related disciplines in the clinical trial setting
- Proven leadership experience managing teams and driving strategic initiatives in matrixed, fast-paced clinical development environment
- Deep understanding of clinical trial operations across all phases of development, 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 (e.g. 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
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 that are 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 the sample collection and assay plans and clinical protocols, to support regulatory filings and approval
- Partner with Quality and Compliance functions to uphold standards across biomarker operations, ensuring audit readiness and adherence to internal and external regulatory expectations
- 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
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Industry
Chemical Manufacturing
Number of Employees
5,001-10,000 employees
