Senior Director, Biomarkers (Immunology)
Vertex Pharmaceuticals
August 15, 2026
Remote friendly (Seattle, WA)
United States
Clinical Research and Development
General Summary:
The Senior Director, Biomarkers, Immunology is an independent leader with expertise in immunology and biologics to drive biomarker strategy across the immunology portfolio, including identification, selection, and development of biomarkers. Experience authoring and supporting regulatory filings is required. Expert in assay development and validation; works with a team and external CROs to ensure fit-for-purpose biomarker assay validation. Specialized technical expert in biomarker development areas (e.g., CDx, immunoassays, genomic assays, flow assays) who leads workstreams and mentors the team.
Key Duties And Responsibilities:
- Lead development and execution of biomarker strategies aligned with cross-functional stakeholders and senior management (immunology/autoimmune focus).
- Oversee assay development, validation, and execution across platforms (flow, immunoassays, genomic assays, NGS, imaging) at CROs and internally; guide data analysis/interpretation.
- Translate preclinical discoveries into clinical biomarker strategies; identify mechanism-relevant biomarkers for drug tailoring.
- Manage and mentor a global biomarker team; align best practices across PreClinical Sciences, Research, Translational, Clinical Development, Clinical Operations, and Bioinformatics.
- Liaison with internal/external stakeholders including diagnostic vendors and scientific partners.
- Communicate complex biomarker strategies to cross-functional teams and senior leaders; demonstrate advanced expertise and enterprise thinking.
- Collaborate to meet project deliverables; adapt to emerging biomarker development/validation trends.
Knowledge And Skills:
- Advanced immunology, biomarker development, and translational medicine knowledge.
- Experience in autoimmune disease research or immunology therapeutic pipelines.
- Ability to communicate complex strategies; strong written/verbal skills.
- Deep drug development process knowledge; experience with early and late-stage programs preferred.
- Strategic/agile thinking; collaborative cross-functional leadership.
- Excellent mentor for fit-for-purpose assay development.
Education And Experience:
- PhD (immunology/biochemistry/molecular biology/molecular pharmacology or related) + 11+ years, or
- Master’s + 15+ years, or
- Bachelor’s + 20+ years.
- Typically 5+ years managing experience.
- Ability to translate preclinical biomarkers into clinical application.
Application Instructions:
- Not provided in the text.
The Senior Director, Biomarkers, Immunology is an independent leader with expertise in immunology and biologics to drive biomarker strategy across the immunology portfolio, including identification, selection, and development of biomarkers. Experience authoring and supporting regulatory filings is required. Expert in assay development and validation; works with a team and external CROs to ensure fit-for-purpose biomarker assay validation. Specialized technical expert in biomarker development areas (e.g., CDx, immunoassays, genomic assays, flow assays) who leads workstreams and mentors the team.
Key Duties And Responsibilities:
- Lead development and execution of biomarker strategies aligned with cross-functional stakeholders and senior management (immunology/autoimmune focus).
- Oversee assay development, validation, and execution across platforms (flow, immunoassays, genomic assays, NGS, imaging) at CROs and internally; guide data analysis/interpretation.
- Translate preclinical discoveries into clinical biomarker strategies; identify mechanism-relevant biomarkers for drug tailoring.
- Manage and mentor a global biomarker team; align best practices across PreClinical Sciences, Research, Translational, Clinical Development, Clinical Operations, and Bioinformatics.
- Liaison with internal/external stakeholders including diagnostic vendors and scientific partners.
- Communicate complex biomarker strategies to cross-functional teams and senior leaders; demonstrate advanced expertise and enterprise thinking.
- Collaborate to meet project deliverables; adapt to emerging biomarker development/validation trends.
Knowledge And Skills:
- Advanced immunology, biomarker development, and translational medicine knowledge.
- Experience in autoimmune disease research or immunology therapeutic pipelines.
- Ability to communicate complex strategies; strong written/verbal skills.
- Deep drug development process knowledge; experience with early and late-stage programs preferred.
- Strategic/agile thinking; collaborative cross-functional leadership.
- Excellent mentor for fit-for-purpose assay development.
Education And Experience:
- PhD (immunology/biochemistry/molecular biology/molecular pharmacology or related) + 11+ years, or
- Master’s + 15+ years, or
- Bachelor’s + 20+ years.
- Typically 5+ years managing experience.
- Ability to translate preclinical biomarkers into clinical application.
Application Instructions:
- Not provided in the text.