Summary
#LI-Hybrid
Primary Location: London, UK
Other Locations: Dublin, Ireland
Relocation Support: This role is based in London/Dublin. Novartis is unable to offer relocation support: please only apply if accessible.
About the Role
Responsibilities:
- Serves as core member of the BDST and as subject matter expert at the Global Clinical Team (GCT) and/or Clinical trial team (CTT) as applicable. As well as externally e.g. steering committees.
- Contributes to the Dx target product profile (DxTPP), and the overall IVD/ CDx development strategy and plan.
- Authors the biomarker/CDx portions of the study protocols and clinical study reports.
- Avoids strategic and operational crises by proactively identifying and managing potential risks to the program(s) and communicate them timely to GCT/CTT to minimize impact on program.
- Supports regulatory submissions by acting as biomarker/clinical Dx subject matter expert within the GCT/CTT team.
- Partners with CBS and other internal stakeholders to ensure all aspects of data collection and analysis are executed with high quality including statistical analysis plan, data formatting and transfer specifications, eCRF page design, and monitoring plans for biomarker study samples.
- May Support exploratory/scientific external academic collaborations to support biomarker data generation.
- Ensures Compliance to applicable US and international Medical Device regulations and standards including, but not limited to, 21 CFR 820, ISO 13485, 93/42/EEC, 98/79 EC, and the requirements of the Novartis CDx Quality Management System.
Essential for the role:
- Education: MD or Ph.D. OR MD/Ph.D. with minimum of 6 years of experience in the field of precision medicine including CDx/IVD and minimum of 3 years in the pharmaceutical industry.
- 3+ years multi/cross functional leadership experience within either or Oncology, Immunology, Neuroscience, Cardiometabolic business unit.
- Excellent knowledge of diagnostics and associated regulatory requirements
- Expert leadership skills demonstrated in cross functional teams.
- Expert skills to facilitate/optimise contribution of team members as individuals and member of cohesive team.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
