Résumé
development, scientific and technical expertise for successful implementation and execution of the Precision Medicine plans for clinical studies in a given program with a focus on ensuring timely execution to meet studies timelines.
About the Role
Major accountabilities:
- 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.
Minimum Requirements:
- 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.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Benefits & Rewards | Novartis
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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.
