Senior Principal Research Scientist, Biomarkers Lead; Immunology

Senior Principal Research Scientist, Biomarkers Lead (Immunology)

General

Summary:

The Biomarkers Senior Principal Research Scientist (Associate Director) is an independent leader with advanced scientific knowledge and expertise in biomarker development. They develop and implement the clinical biomarker strategy for one or more programs and execute the biomarker plan during clinical development with minimal guidance. Authoring and supporting regulatory filings is required. An expert in assay development and validation, the incumbent collaborates with a team and external CROs to ensure fit‑for‑purpose validation of biomarker assays.

The candidate is a specialized technical expert in areas such as CDx, immunoassays, genomic assays, flow assays, etc., capable of leading specific work streams, building biomarker capabilities, and mentoring team members.

• Develop and align the biomarker strategy cross‑functionally.
• Oversee the development, validation, and timely implementation of fit‑for‑purpose biomarker assays for clinical phase programs in accordance with regulatory guidance, including providing supportive written documentation.
• Serve as key point of contact for internal and external stakeholders regarding assay design requirements (patient selection, target engagement, pharmacodynamic, and mechanism of action biomarkers).
• Manage assay activities performed at external vendors and guide the development and utilization of assays in GCLP settings.
• Establish strong relationships with diagnostics vendors and CROs, leveraging both internally developed and third‑party assays.
• Represent biomarker science at cross‑functional teams and be responsible for all key biomarker deliverables for the program(s).
• Present and communicate biomarker data and strategy at cross‑functional meetings and to senior management.
• Represent Vertex at external conferences, meetings, and discussions to present on biomarker development and validation.
• Lead specialized technical work streams and develop new expertise within the team to strengthen biomarker capabilities.
• Resolve complex problems with broad implications for the organizational function.

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

• Ph.D. (or equivalent) in immunology or a relevant scientific field and 6–8 years of relevant experience.
• Or Master's degree (or equivalent) and 9+ years of relevant employment experience.
• Or Bachelor's degree (or equivalent) and 12+ years of relevant employment experience.

$154,600 – $231,800

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job‑related factors permitted by law.

Vertex offers inclusive, market‑leading benefits covering medical, dental, vision, paid time off, educational assistance, commuting subsidy, charitable donations, 401(k), and more.

Hybrid‑Eligible or On‑Site Eligible

• Hybrid: work remotely up to two days per week.
• On‑Site: work five days per week on‑site with ad hoc flexibility.

Note:

The Flex status for this position is subject to Vertex’s policy on the Flex @ Vertex Program and may change at any time.

Vertex is a global biotechnology company that invests in scientific innovation.