Résumé
About the Role
Major accountabilities:
- Develops the assigned program Precision medicine strategy aligned to the disease area strategy in support of a GCT/GPT and ensures seamless execution for the success of the program.
- Leads cross functional biomarker sub teams for molecular epidemiology, assay development for patient selection/stratification, data analyses/interpretation and data reporting.
- Serves as core member of the BDST and may lead BDST. Serves as subject matter expert at the Global Clinical Team (GCT) and/or Clinical trial team (CTT) as applicable.
- Contributes to the Dx target product profile (DxTPP), and the overall IVD/ CDx development strategy and plan.
- Avoids strategic and operational crises by proactively identifying and managing potential risks to the program(s).
- Authors the biomarker/CDx portions of key clinical documents including Clinical Development Plan, Investigator Brochures, Clinical study protocols and Study Reports
- Supports regulatory submissions by acting as biomarker/clinical Dx subject matter expert within the GPT team.
- 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:
Work Experience:
- 6 years industry experience
- 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.
- Strong interpersonal and communication skills for bridging scientific and business participants, for negotiating timelines and for effective international collaboration.
- Outstanding verbal and written communications
- Results driven
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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 diversity.inclusion_ch@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
