Biomarker Scientific Monitor and BMD Study Expert/Coordinator

Band Level 4 Job Description Summary #LI-Hybrid Location: Cambridge Internal Title: Principal Scientist I 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. 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. Lead the implementation of innovative and global external solutions and best practices across BMD Independently provide end-of-end support for exploratory and regulated 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. Oversee regulated Biomarkers activities at ESPs within compliance requirements. 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 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 Responsibilities: 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 Exposure to regulated bioanalysis/biomarkers and regulatory compliance is 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, fluent in English as a working language The salary for this position is expected to range between: $108,500-$201,500/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. To learn more about the culture, rewards and benefits we offer our people click here 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, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. 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 in order to perform the essential functions of a position, please send an e-mail to View email address on click.appcast.io call View phone number on click.appcast.io and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $108,500.00 - $201,500.00 Skills Desired Analytical Skill (Inactive), Analytical Skill (Inactive), Analytical Thinking, Chemical Biology, Chemistry, Clinical Trials, Collaboration, Communication Skills (Inactive), Curious Mindset, Data (Inactive), Data Analysis, Design of Experiments (DOE), Detail-Oriented, Drug Development, Drug Discovery Process, Ethics, Gene Therapy, Immunology, Inventory Management, Laboratory (Inactive), Leading Project Teams, Lifesciences (Inactive), Machine Learning (ML), Management (Inactive), Medical Research {+ 10 more} Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. 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