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Job Description Summary

Job Description

Your responsibilities will include, but not limited to:

• As Molecular & Cellular Sciences (MCS) biomarker lead and member of the biomarker and diagnostic strategic team (BDST), you will provide scientific and technical insights, contribute to the overall clinical study biomarker strategy and plan to enable proof of mechanism, proof of biology, safety and efficacy understanding and patient selection.

• As MCS biomarker lead in clinical studies, you will work with biomarker experts to define and lead the execution of cellular and soluble biomarker plan and the successful implementation of internal and external “fit for purpose” biomarker assays.

• Develop, validate and implement cellular and soluble biomarker assays by working with internal labs as well as external lab partners

• Manage activities and supervise laboratory in compliance with Novartis guidelines and Good Clinical Practice.

• Select and evaluate new innovative soluble and cellular biomarker technologies to cover biomarker needs and gaps in early and late projects.

• Partner with outsourcing functions to evaluate new CROs, drive transitioning and monitoring of internally developed assays to external vendors.

• Generate and interpret data to enable proof of mechanism, dose selection & proof of biology across early clinical programs and present results at internal meetings

• Ensure high quality and timely delivery of results

• Contribute/write quality reports and laboratory manuals.

• Cross train a variety of biomarker modalities and technologies

What you will bring to the role:

• PhD in Biology, Immunology or cell biology or equivalent related experience and 5+ years of industry experience in biomarker assay development and validation or related fields 

• Extensive understanding and experience in high dimensional flow cytometry (conventional and spectral flow cytometry) and multiplex ligand binding assay technologies (e.g. MSD, Ella, NULISA, Olink) and related software/bioinformatic tools for data analysis is required

• Extensive experience in technical development, validation, and implementation of cellular and soluble biomarker assays in clinical studies according to international guidelines

• Experience in outsourcing and leading activities at CROs (e.g. technical troubleshooting)

• Good Computer skills (Excel, Word, PowerPoint, Soft MaxPro, SMART Book, Spotfire, GraphPad Prism, Watson LIMS)

• Solid understanding of tools, practices and processes employed in clinical trial settings and drug development

• Understanding of regulatory requirement relevant to Biomarker Development (e.g. GCLP, ICH)

• Proven ability to work and lead in a global matrix organizational and scientific environment

• Experience working in a global organization and matrix-resourcing model

• Good communication skills for oral and written in English

*Restrictions on flexible working arrangements may apply and will be discussed at interview if applicable

Accessibility and accommodation

Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Skills Desired