Senior Principal Research Scientist, Biomarkers Lead (Immunology)

Job Description

General Summary:

The Biomarkers Senior Principal Research Scientist (Associate Director) is an independent leader with advanced scientific knowledge and expertise in biomarker development who develops and implements the clinical biomarker strategy for one or more programs and implements the biomarker plan during clinical development with no/minimal guidance. Experience in authoring and supporting regulatory filings and applicable areas of these filings is 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 candidate is a specialized technical expert in specific areas in biomarker development (e.g. CDx, immunoassays, genomic assays, flow assays, etc.) who can lead specific workstreams and capabilities within the group and mentor others within the team.

Key Duties and Responsibilities:

• Develops and aligns the biomarker strategy cross-functionally.
• Provides expert oversight of the development, validation, and timely implementation of fit-for-purpose biomarker assays for clinical phase program in accordance with regulatory guidance, along with providing supportive written documentation
• Serves as key point of contact for internal and external stakeholders regarding assay design requirements, e.g. patient selection, target engagement, pharmacodynamic, and mechanism of action biomarkers.
• Responsible for assay activities performed at external vendors and providing guidance requirements for developing and utilizing assays in GCLP settings.
• Establishes strong working relationships with key diagnostics vendors and CROs that will employ assays both developed internally at Vertex and at an external vendor.
• Represents biomarker at key cross-functional teams and responsible for all key biomarker deliverables for the program(s).
• Presents and communicates biomarker data and strategy at cross-functional team meetings and to senior management.
• Represents Vertex at external conferences, meetings, and discussions to present topics on biomarker development and validation.
• Leads specific workstreams and capabilities as a specialized technical expert and develops new expertise within the group to build the biomarker capability within the team.
• May resolve complex problems with wide-reaching implications for the organizational function.

Knowledge and Skills:

• At least 9+ years of experience and scientific achievement in biotech / pharmaceutical drug discovery and development
• Experience in translating disease biology and translational science data of therapeutic agents 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 and Experience:

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

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Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

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 person's 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 ApplicationAssistance@vrtx.com