This person leads cross functional R&D teams (NAT Chemistry, Bioinformatics, Biostatistics, Proteomics, Systems Engineering) in the development phase of CDx diagnostic assays and products.
Works with the Global Project Director in the cross functional leadership of diagnostic development teams to plan and execute on deliverables Coordinates and integrates plans with key external partners as appropriate On-time, on-budget delivery of project team commitments Develops budgets for programs and negotiates resources from functional heads Adherence of program plans to ISO, CE, FDA, and other 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.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
-BS, MS, or PhD degree in science discipline
-7 years development of in vitro diagnostic products, with evidence of products(s) on the market Success through FDA/CE/MHLW regulatory process
-Experience managing cross-functional teams and in resource planning
-Experience using MS Project Software Experience in Design for Six sigma preferred
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