Biomarker Monitor and BMD Study Expert, Laboratory Excellence and Operations(LEO)

Job Description Summary

#LI-Hybrid

Internal Title : Principal Scientist II

As a BMD Study Expert in LEO you will be driving patient-centric operational innovation and partnership with external service providers / CROs and internal subject matter experts. Laboratory Excellence and Operation (LEO) is the key global resource for Line functions (LF) and Biomedical Research (BR) Clinical Trial Teams for biomarkers including biomarker outsourcing, scientific bi-omarker 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.

Job Description

Key Responsibilities :

• Place, implement and monitor biomarker assays at external service providers (ESP) across several biomarker modalities (e.g. Immunoassay, LC-MS, Flow cytometry, genetics etc.) in Translational Medicine (TM) clinical studies. Support data transfer and data flow in LIMS and DTS (e.g. study creation, data flow, data transfer, etc.) for managed biomarkers and studies. Partner with ESP to ensure on time / quality deliverables
• Independently identify and resolve assay issues as well as ESP quality or performance issues. Engage partner LF SME, clinical trial leaders and data management and other teams in complex issue resolution and escalations
• 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. Lead the implementation of innovative and global external solutions with central labs, clinical sites and external service providers for BMs and lead best practices across BMD
• Serves as a Biomarker 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
• Provide input and review clinical study protocols, CSRs, site operations manuals, informed consent forms, sample collection table, instruction manuals, central lab protocol / manual, and eCRF and other sample / biomarker / assay / vendor setup, sample tracking / reconciliation, and data flows
• Collaborate with other TM and BMD functions and lead biomarker clinical operation processes, continuous improvement initiatives and innovations in LEO and BMD.
• Provide mentorship to colleagues in LEO and BMD.

Essential Requirements :

Education :

Professional Experience :

Languages :

Fluent in English as a working language.

The salary for this position is expected to range between $114,100 and $211,900 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

EEO Statement :

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$114,100.00 - $211,900.00

Skills Desired

Analytical Skill, Analytical Skill, Analytical Thinking, Chemical Biology, Chemistry, Clinical Trials, Collaboration, Communication Skills, Curiosity, 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}