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Research Fellow (Associate Director / Director), Biomarker Assay Development and Validation

Company: Vertex Pharmaceuticals Inc (US)
Location: Boston
Posted on: September 17, 2020

Job Description:

The Research Fellow I/II (Associate Director / Director level), Biomarker Assay Development and Validation will be an experienced, hands-on leader that designs, builds, and delivers high quality, fit-for-purpose biomarker assays that enable drug development at Vertex. As a leader within the Biomarkers function, the Research Fellow I/II will be responsible for biomarker assay development across one or more disease areas. Biomarker assay purposes will include patient selection, target engagement, and biological/clinical response biomarkers, and will include nucleic acid and protein based approaches. The Research Fellow I/II will use internal and external resources to optimize biomarker assays intended for clinical use, and will share joint responsibility with other biomarker functions for developing and executing biomarker plans.

Key Responsibilities:

* Provide expert oversight of the development, validation and deployment of fit-for-purpose assays suitable for preclinical and/or clinical decision-making, with an emphasis on clinical assay development * Serve as key point of contact for internal and external stakeholders regarding assay design requirements for patient selection, target engagement, and mechanism of action biomarkers. * Serve as a primary internal subject matter expert/liaison interfacing with the Vertex Regulatory team regarding regulatory requirements pertaining to both analytical validation of assays. * Collaborate to ensure appropriate assays are delivered for assay development and validation. * In a matrixed environment, construct and validate high quality protein, nucleic acid, and molecular pathology assays suitable for a range of tissue types (serum, plasma, blood cells, solid tissue, other body fluids). * Be responsible for assay development activities performed at external vendors. * Provide expert guidance regarding requirements for developing and utilizing assays in GLP and GCP settings. * Work with Translational Medicine, Clinical Development, and Regulatory colleagues to ensure that assays suitable to Health Authority requirements are ready in time for clinical use, along with providing supportive written documentation of assay characteristics and validation. * Establish strong working relationships with key diagnostics vendors and CROs that will employ assays developed at Vertex.

Qualifications sought:

* Expert assay development and validation scientist (with at least 7-10 years post-degree experience in development of clinical assays used in registrational clinical trials and 3-5 years of additional relevant experience). (MD and/or PhD training). * Experience in developing genetic, protein, and molecular pathology assays in a variety of disease contexts. * Excellent mentor for scientists working on fit-for-purpose assay development * Excellent interpersonal skills, able to drive global collaborations across a matrixed organization. * Demonstrated experience with fit-for-purpose assay development.

#LI-MH1

Keywords: Vertex Pharmaceuticals Inc (US), Boston , Research Fellow (Associate Director / Director), Biomarker Assay Development and Validation, Executive , Boston, Massachusetts

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