Senior Director, Biomarkers (Immunology)

Job Description

General Summary: The Senior Director Biomarkers Immunology is an independent leader with wide-reaching scientific knowledge and expertise in immunology and biologics that can drive the biomarker strategy across the immunology portfolio including in the identification selection and development of biomarkers. Experience in authoring and supporting regulatory filings required. The incumbent is an expert in the field of assay development and validation and works with a team and several external CROs to ensure fit-for-purpose validation of biomarker assays. The incumbent is a specialized technical expert in specific areas in biomarker development (e.g. CDx immunoassays genomic assays flow assays etc.) who can lead specific work streams and capabilities within the group and mentor others within the team.

Key Duties and Responsibilities:

• Leads the development and execution of biomarker strategies in alignment with cross-functional stakeholders and senior management with a focus on immunology and autoimmune disease programs.
• Oversees assay development validation and execution of biomarker assays across various platforms (e.g. flow assays immunoassays genomic assays NGS imaging biomarkers) at CROs and internally providing guidance on data analysis and interpretation.
• Translates preclinical discoveries into clinical biomarker strategies identifying mechanism-relevant biomarkers to support drug tailoring hypotheses.
• Manages and mentors a diverse biomarker team ensuring alignment of best practices across global sites including PreClinical Sciences (PCS) Research Translational Clinical Development Clinical Operations and Bioinformatics teams to ensure robust biomarker strategy execution.
• Serves as a key liaison with internal and external stakeholders including diagnostic vendors and scientific partners.
• Effectively communicates complex biomarker strategies to cross-functional teams and senior leaders.
• Demonstrates advanced scientific expertise in immunology biomarker development and translational medicine.
• Possesses a strong understanding of the drug development process and showcases enterprise thinking. Experience with late-stage program development is highly preferred.
• Brings strategic agility and late-stage program experience to adapt to emerging trends in biomarker development.
• Collaborates across business areas and diverse functional stakeholders to successfully meet project deliverables

Knowledge and Skills:

• Advanced scientific knowledge in immunology biomarker development and translational medicine.
• Experience with autoimmune disease research or immunology therapeutic pipelines.
• Ability to communicate complex immunology-based biomarker strategies to cross-functional partners and senior leaders including research clinical operations regulatory program leadership and non-immunology scientists.
• Experience with working on cross-functional teams in the biotech/ pharma industry showcasing enterprise thinking.
• Has deep knowledge of the drug development process and a broad perspective of the business.
• Experience with both early and late-stage programs preferred
• Ability to apply strategic and agile thinking to adapt to the emerging trends in biomarker development/validation.
• Strong written and verbal communication skills and the ability to effectively communicate with cross-functional teams and present complex science clearly to various stakeholders within the organization.
• Ability to work collaboratively across business areas and with diverse functional stakeholders to successfully meet project deliverables.
• Excellent mentor for scientists and employees working on fit-for-purpose assay development
• Demonstrated expertise with fit-for-purpose assay development

Education and Experience:

• PhD in Immunology Biochemistry Molecular Biology Molecular Pharmacology or related field and 11 years of experience or
• Masters degree and 15 years of relevant employment experience or
• Bachelors Degree and 20 years of relevant employment experience.
• Typically requires 5 years of managing experience.
• Demonstrated ability to translate preclinical biomarkers into clinical application.

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Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

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Company Information

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

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at