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Subject matter expert • windsor on
- Promoted
Precision Medicine Director
Healthcare Businesswomen’s AssociationON, Canada- Promoted
Digital product owner
BMO Financial GroupON, Canada- Promoted
Manager, Marketing Communications
IFG International Financial Group LtdON, Canada- Promoted
Expert en sinistres, niveau I – Dommages corporels
Co-operators Assurance et services financiersON, CanadaTopics in Visual Culture and Communication - Visual Culture and the Politics of Reproduction
University of TorontoOntario, Canada- Promoted
Workday configuration consultant
Société Financière ManuvieON, Canada- Promoted
Manager, Grid Operations & Emergency Management
PSG leadership Inc.Regional Municipality of Durham, ON, Canada- Promoted
Principal Data Scientist I
LexisNexis Risk SolutionsON, Canada- Promoted
Relationship Manager - MEP
Pinnacle InfotechON, Canada- Promoted
Process Documentation & Control Consultant
Sun LifeON, Canada- Promoted
Senior Specialist, Compensation
David Aplin RecruitingGolden Horseshoe, ON, CanadaChange, Learning and Communications Senior Manager
Meridia Recruitment SolutionsOntarioMarketing Strategist and Content Creator
Rules CubeCanada, ON, CA- Promoted
Engineering Change Analyst, Associate (12 Month Contract)
Harris Geospatial SolutionsGolden Horseshoe, ON, CanadaPERMANENT : 1.0 FTE; English & Another Subject
York Region District School BoardOntario, CanadaSupply Chain Manager (Blue Box)
Mier Human Capital MoreoverHalton Region, ON- Promoted
Manager, Total Loss
Allstate Insurance CompanyON, CanadaPMS Solution Expert
Straumann GroupHaltonRegional Manager
Ontario Medical AssociationRemote- Northern Ontario, ON, Canada- Promoted
Product Manager, Group Retirement Savings
Empire LifeOntario, Canada, CanadaPrecision Medicine Director
Healthcare Businesswomen’s AssociationON, Canada- Full-time
Job Description Summary
The Precision Medicine Director (PMD) develops the Precision Medicine strategy and plans for a given program. The PMD leads and oversees all aspects of implementation and execution of the program PM strategy, supporting GCT / GPT including development of clinical biomarker assays with a medical purpose and (companion) diagnostics to support patient selection and stratification ensuring regulatory approval, technical market access and optimised commercial value. Acts as Precision Medicine Subject Matter Expert within the GCT / GPT.
Job Description
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 :
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 [email protected] 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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