Senior Principal Research Scientist, Biomarkers Lead (Immunology)

Role Summary

The Biomarkers Senior Principal Research Scientist (Associate Director) leads biomarker development strategy for clinical programs, implementing biomarker plans during clinical development with minimal guidance. Requires experience authoring/regulatory filings and expertise in assay development/validation, coordinating with internal teams and external CROs. Serves as a technical expert in biomarker areas (e.g., CDx, immunoassays, genomic/flow assays) to lead workstreams and mentor others.

Responsibilities

• Develops and aligns the biomarker strategy cross-functionally.
• Provides expert oversight of development, validation, and implementation of fit-for-purpose biomarker assays for clinical programs in accordance with regulatory guidance, with supportive documentation.
• Serves as key point of contact for stakeholders regarding assay design requirements (patient selection, target engagement, pharmacodynamic, MOA biomarkers).
• Oversees assay activities at external vendors and provides guidance for developing and utilizing assays in GCLP settings.
• Establishes relationships with diagnostics vendors and CROs that will use assays developed internally and externally.
• Represents biomarker at cross-functional teams and is responsible for biomarker deliverables for programs.
• Prepares and communicates biomarker data and strategy at team meetings and to senior management.
• Represents Vertex at external conferences and discussions on biomarker development and validation.
• Leads specific workstreams as a specialized technical expert and builds biomarker capability within the team.
• Resolves complex problems with wide-reaching organizational impact as needed.

Qualifications

• At least 9+ years of experience and scientific achievement in biotech/pharmaceutical drug discovery and development
• Experience translating disease biology and translational data into clinical biomarkers for patient selection and monitoring
• Expertise in standard immunological assays; strong foundation in assay validation under regulatory conditions (GCLP, GLP, IVD)
• Experience in selection and oversight of clinical trial biomarker assay vendors
• Must have clinical trial experience; global late-stage trial experience preferred

Education

• Ph.D. (or equivalent) in immunology or relevant field with 6-8 years of experience
• Master's Degree with 9+ years of experience, or
• Bachelor's Degree with 12+ years of experience