Biomarker Clinical Assay Lead (Manager)

$99,900 - $166,500/Yr

Pfizer - San Diego, CA

Full-time - Manager

San Diego, CA

Chemical Manufacturing

About the position

The Biomarker Clinical Assay Lead (Manager) at Pfizer plays a crucial role in the Oncology team, providing scientific and technical oversight for clinical trial biomarker sample analyses. This position involves managing both internal and external partners to ensure high-quality biomarker data delivery, leading assay development, and troubleshooting complex issues. The role also includes strategic direction for continuous improvement efforts and maintaining compliance with clinical laboratory standards.

Responsibilities

• Provide biomarker bioanalytical assay technical and operational expertise to Study Teams.
• Lead novel assay development and ensure timely availability of oncology clinical biomarker assays.
• Troubleshoot and resolve complex technical and logistical issues at vendors.
• Evaluate complex data critically and guide the team in broader interpretation of data.
• Function as the key point of contact with external and internal clinical laboratories, overseeing agreements, work plans, budgets, and data quality.
• Lead and provide technical support for selection, qualification, and audits of CRO laboratories.
• Coordinate with Study Teams to ensure appropriate biomarker sample handling and processing steps are described in the clinical trial Laboratory Manual.
• Contribute to biomarker CRF selection and lead data transfer development with laboratories and data management groups.
• Lead the development of best practice processes and templates.
• Provide strategic direction for internal and external continuous improvement efforts.

Requirements

• PhD with 2+ years of industry or clinical laboratory experience in Oncology biomarker assay development, validation, and implementation, or MS with 4+ years, or BS with 7+ years of relevant experience.
• Strong track record of publications or conference presentations in IHC, Flow Cytometry, and Molecular Oncology assays.
• Extensive knowledge of clinical laboratory regulatory and compliance requirements (e.g., GCLP, CAP, CLIA).
• Strong verbal and written communication skills.

Nice-to-haves

• Experience with clinical or companion diagnostics.
• Experience training Manager level colleagues.
• Extensive CRO management and outsourcing engagement experience.
• Experience with Oncology specialty platforms, Molecular Oncology, or Hematopathology.
• Clinical Lab Science (CLS) or ASCP certification.

Benefits

• Paid holidays
• Relocation assistance
• Health insurance
• Dental insurance
• Parental leave
• Vision insurance
• 401(k) matching