Director, Biomarker and Assays

Proclinical, in support of our client, are seeking an individual to fill the role of Director of Biomarkers and Assays, based in New York, NY. The successful candidate will drive, support and contribute to the implementation of the clinical biomarker strategy for multiple therapeutics.

Responsibilities

• Manage the development of companion diagnostics in collaboration with appropriate vendors and other stakeholders.
• Select centralized testing vendors and assays to best investigate the clinical biomarkers and mechanism-of-action questions.
• Oversee assay development and validation of assays at CROs.
• Oversee implementation of clinical trial assays at centralized testing vendors
• Remain up to date on new technologies, methods, and regulatory expectations.
• Perform data analysis of various assays.
• Draft reports for internal and external stakeholders.
• Review, summarize, document, and prepare data for databases and formal reports.
• Trend data on per patient and per group basis to discover meaningful correlations and trends.
• Draft regulatory documents for biomarker and companion diagnostics.
• Maintain knowledge of applicable regulatory requirements and relevant scientific/technical issues.
• Generate and maintain clinical SOPs and SOWs to support technical work at sites.
• Manage contracts, budgets and timelines.
• Maintain involvement in a wide spectrum of R&D functions.

Skills And Qualifications

• PhD in immunology, virology or other related disciplines and 5+ years of pharma research related experience.
• Experience and knowledge with some of the following assays: virus plaque assays, RT-qPCR and RT-PCR, western blots, IHC, immunoassays, nAb assays, NGS, RNAseq, etc.
• Experience in development and validation of clinical assays at CROs.
• Experience with outsourcing and monitoring of clinical assays.
• Strong written, verbal, and interpersonal communication skills.
• Strong knowledge of Microsoft Office suite.
• Ability to travel as required

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Andrew Shen at (+1) 646-367-1089 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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