摘要
Laboratory Excellence and Operation (LEO) is the key global resource for Line functions (LF) and Translational Medicine (T M) 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 external service providers (ESP) including central labs and clinical sites.
#LI-Hybrid
About the Role
Key Responsibilities:
- Serves as a single Biomarker development (BMD) clinical team (CTT) representative (Biomarker Study Expert) on selected clinical studies and develop and operationalize biomarker plans partnership with BMD LF and TA
- Develops and provides operational reviews of clinical study protocols, site operations manuals, informed consent forms, sample collection table, instruction manual, central lab protocol/manual, and eCRF and other biomarker sample logistics including study setup, sample tracking/reconciliation, assay set up and sample/data upload covering all samples including safety, biomarkers, PK
- Independently places, transfers, implements and monitors biomarker assays at external service providers (ESP) in one or more biomarker modalities (e.g. Immunoassay, LC-MS, Flow cytometry, genetics)
- Supports data transfer and data flow in LIMS and DTS (e.g. study creation, data flow, data transfer, etc.) for managed biomarkers and studies. Update study and project information in relevant IT systems
- Independently identifies, complex assay troubleshooting, sample management issues, ESP, quality or performance issues and engage LF experts, clinical trial leaders and data management as needed.
- Collaborates with other TM and BMD functions, lead site, central lab and vendors processes, continuous improvement initiatives and innovations in LEO
Minimum Requirements:
- BS in life science with 2+ years of clinical operations and/or bioanalysis experience.
- To be considered at the Senior Scientist II level must have a minimum of 5+ years or advanced degree with 2+ years of related experience.
- Strong project management, problem solving, communication and leadership skills.
Desirable Requirements:
- laboratory knowledge of immunoassays and/or bioanalysis and/or cellular biomarkers
- Scientific knowledge of clinical study set up and operations, clinical sample analysis and managing external service provider (ESP).
- Knowledge of the drug development process, biomarkers and working with clinical teams and translation clinical research.
- In depth/ Knowledge of regulatory requirements e.g. GCP
This is a dual-level posting. The final level and title of the offer role would be determined by the hiring team based on the skills, experience & capabilities required to perform the role at the level the role has been offered.
Novartis Compensation and Benefit Summary:
The pay range for this position at commencement of employment is expected to be between: $85,400 and $158,600/year at the Senior Scientist I level and between: $93,800 and $174,200/year at the Senior Scientist II level; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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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 & 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 [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
