Biomarker Scientific Monitor and BMD Study ExpertCoordinator (80-100)

Band

Level 4

Job Description Summary

Laboratory Excellence and Operation (LEO) is the key global resource for Line functions (LF) and BR Clinical Trial Teams for biomarkers including biomarker outsourcing scientific biomarker monitoring vendor management biomarker logistics clinical site communication and sample coordination. LEO is working in close collaboration with clinical teams LF technology experts Biomarker Leads (BMLs) as well as specialized external service providers (ESP) central labs and clinical sites.

#LI-Hybrid
Location: Basel
Internal Title: Principal Scientist I

Job Description

Key Responsibilities:

• Act as a portfolio scientific monitor and oversee one or more strategic vendors. Lead development of strategic ESPs including on boarding planning communication oversight and act as a point of contact to ESP and SME at the BMD level. Leadthe implementation of innovative and global external solutions andbest practices across BMD
• Independently provide end-of-end support for biomarkers at external service providers (ESP) including placing implementing and monitoring biomarker assays (e.g. Immunoassay flow cytometry etc.) in TM clinical studies. Partner with ESP and internal teams to ensure on time/quality deliverables
• Independently identify assay quality or performance issues. Resolve and engage LF SME clinical trial leaders data management and other teams in complex issue resolution and escalations!
• Support data transfer and data flow (e.g. DTS etc.) for managed biomarkers and studies. Update study and project information in relevant IT systems
• Contribute to BR and TM integration efforts (companies clinical assets etc.) including vendor and assay planning reviews and transition activities
• Serve as a BMD Study Expert BSE and clinical team representative from BMD on selected clinical studies and/or at a project level. Partner with clinical teams and functions
• Collaborate with other TM and BMD functions and lead biomarker clinical operation processes continuous improvement initiatives and innovations in LEO and BMD.

Essential Requirements:

• MS in life science with 6 years of clinical operations experiences and/or clinical bioanalysis and/or clinical biomarkers. PhD with 3 years in clinical operations and/or clinical bioanalysis and/or clinical biomarkers
• Emerging leader who is passionate about biomarkers operational innovation and partnership with external service providers/CROs and internal subject matter experts
• Laboratory knowledge and experience with one or several biomarker modalities and/or bioanalytical platforms e.g. immunoassays LC-MS/mass spectrometry cellular biomarkers
• Direct experience with external integration efforts (external companies and clinical assets) and biomarker/vendor planning and transition is highly desired.
• Experience in troubleshooting of assays in CRO and assay transfer to CROs as well as managing relationship and performance of external service providers/CROs including specialized laboratories is highly desired.
• Deep knowledge of clinical study set up and clinical operations clinical sample analysis
• Extensive of the drug development process biomarkers and working with clinical translation research or global clinical studies
• Experience working in a global organization and matrix environment (multiple roles/connections and stakeholders)
• Strong global project management problem solving influencing communication and leadership skills.
• In depth/expert knowledge of regulatory requirements e.g. data integrity GCP GLP etc.
• Concise oral and written communication skills

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 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Skills Desired

Analytical Skill Analytical Skill Analytical Thinking Chemical Biology Chemistry Clinical Trials Collaboration Communication Skills Curious Mindset Data Data Analysis Design Of Experiments Detail-Oriented Drug Development Drug Discovery Ethics Gene Therapy Immunology Inventory Management Laboratory Lifesciences Machine Learning (ML) Management Medical Research Molecular Biology 10 more