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Principal/Senior Scientist, Clinical Biomarker New

12215df73cfb

Prevail Therapeutics

Negotiable

New York, United States

United States

Other

ASAP

04/05/2021

03/06/2021

Not specified

Permanent | Full Time

Position SummaryThe Principal/Senior Scientist, Clinical Biomarker Lead, will report to the Director, Bioanalytical & Biomarkers and have the responsibility to deliver biomarker strategies and biomarker translation from discovery/preclinical to the early phase of clinical development phase of novel gene therapy targets for neurodegenerative disorders. In addition, he/she will contribute to supporting the implementation of these biomarker strategies in clinical programs. The Clinical Biomarker Lead will be an integral member of one or more clinical teams.Key Responsibilities* Provide biofluid and/or imaging biomarker expertise to support the development and implementation of biomarker strategies* Accounspan for identifying and evaluating relevant biomarker technologies/platforms* Lead the planning, review, trouble-shooting, interpretation and reporting of biofluid and imaging biomarker studies to ensure delivery of scientific data of high quality* Develop sample collection, tracking and processing procedures; provide guidance on sample management* Lead execution of biomarker strategies with external CROs.* Maintain and apply cutting edge knowledge of developments in imaging and biomarker assays relevant to neurodegenerative diseases and/or gene therapy.* Lead clinical sub-team meetings* Interact with other internal and external teams, including Clinical Development, Clinical Operations, Statistics, Discovery, Preclinical, and Key Opinion Leaders and participate in disease consortia.Requirements* Ph.D. in Neuroscience, Translational Medicine, Molecular Biology or a relevant discipline, with prior experience in the pharmaceutical industry; Title and compensation will be commensurate with experience.* Hands-on experience in clinical biomarker strategy development and execution in gene therapy and/or neurodegenerative disorders is required.* Expertise in analytical molecular biomarker assay and bioimaging experimental design required.* Experience with vendor selection and management* Knowledgeable in biomarker discovery and validation desired.* Working knowledge of GCLP, CAP/CLIA, ICH, FDA guidance publications desired.* Strong interpersonal, organizational, planning, and communication skills.* Ability to work independently and as a team player in multidisciplinary teams.



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