Biomarkers Senior Principal Research Scientist

Vertex Inc.•Seattle, WA

2d•Hybrid

About The Position

The Biomarkers Senior Principal Research Scientist 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 minimal guidance. 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 others to solve complex problems and is able to communicate difficult concepts and persuade others.

Requirements

Has specialized depth and/or breadth of knowledge and skills in Biomarker development and validation
Impacts the achievement of internal/external program objectives.
Communicates difficult concepts and is able to persuade others.
Ability to manage multiple tasks internally and externally and drive towards key deliverables within rigorous timelines
Excellent interpersonal and communication skills, able to drive global collaborations across a matrixed organization.
Innovative and able to think creatively with a strong drive toward decision making.
Ph.D. (or equivalent degree) in Biochemistry, Molecular Biology, Molecular Pharmacology or related field and 6-8 years of experience, or Master’s Degree and 9+ years of relevant employment experience, or Bachelor’s Degree and 11+ years of relevant employment experience

Responsibilities

Develops and aligns the biomarker strategy cross functionally.
Provides expert oversight of the development, validation and implementation of fit-for-purpose biomarker assays for clinical phase program
Serves as key point of contact for internal and external stakeholders regarding assay design requirements for e.g. patient selection, target engagement, pharmacodynamic and mechanism of action biomarkers.
In a matrixed environment, works cross functionally, both internally and externally, to develop and validate high quality assays suitable for a range of matrix and tissue types.
Responsible for assay activities performed at external vendors and provide recommendations regarding requirements for developing and utilizing assays in GCLP settings.
Works cross-functionally to ensure that assays are developed and validated according to regulatory guidance and are ready in time for clinical use, along with providing supportive written documentation of assay characteristics and validation.
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 is 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 conference, meetings, and discussions to present topics on biomarkers development and validation.
Contributes to specific work streams and capabilities as specialized technical expert and develops new expertise within the group to build the biomarker capability within the team.