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Basel-Stadt, Schweiz/Suisse/Svizzera/Svizra
Onsite
Band
Level 3
Job Description Summary
Location: Basel
Job Description
Key Responsibilities:
Act as a portfolio scientific monitor and oversee one or more strategic vendors. Contribute to 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. Support the implementation of innovative and global external solutions and best 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
Support early portfolio as Therapeutic Area (TA) LEO lead role.
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 BMD functions and contribute to biomarker clinical operation processes, continuous improvement initiatives and innovations in LEO and BMD.
Essential Requirements:
BS in life science with 5+ years of experiences or advance degree with 2 years in clinical operations and/or clinical bioanalysis
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
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
Knowledge 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)
Experience in 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 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
Analytical Skill, Analytical Skill, Analytical Thinking, Chemical Biology, Chemistry, Clinical Research, Clinical Trials, Collaboration, Communication Skills, Curious Mindset, Data, Data Analysis, Design Of Experiments, Detail-Oriented, Diversity & Inclusion, Drug Discovery, Ethics, Gene Therapy, Immunology, Laboratory, Lifesciences, Machine Learning (ML), Mammalian Cell Culture, Medical Research, Molecular Biology {+ 11 more}