POSITION SUMMARY: Join Natera as the Director of Development for our Early Cancer Detection (ECD) In Vitro Diagnostic (IVD) products. You will take ownership of the development, verification, and validation of our early cancer detection (ECD) Next Generation Sequencing products from feasibility exit through regulatory submission and post-market support. Every test represents a real person, and you will lead a team of scientists and managers to execute the performance data packages supporting PMA submissions. You will serve as the technical subject matter expert in FDA interactions, partnering across functions to deliver design-controlled diagnostic products that directly impact patient care. PRIMARY RESPONSIBILITIES: Own the execution of the technical strategy and phase-gated process of of development, design verification, and validation studies for ECD IVD devices utilizing cfDNA, methylation and other potential analytes Ensure rigorous compliance with applicable FDA Class III (PMA) design and development requirements Take ownership of the analytical performance strategy (limit of blank/detection, precision, linearity, interference, stability) for ECD assays, partnering directly with Regulatory Affairs (RA), biostatistics, bioinformatics and research teams Contribute to the robust transfer of assays to the commercial laboratory and manufacturing in support of the design transfer and operations teams Partner with clinical and biostatistics leaders on statistical analysis plans required for approvable device performance claims in clinical intended-use populations Think team by partnering directly across bioinformatics, biostatistics, software engineering, clinical, regulatory, and commercial functions to align development efforts with business goals, and drive resourcing and go/no-go recommendations at phase gates Deliver the analytical performance data package supporting Class III PMA submissions, developing a comprehensive approval strategy with RA Serve as t
Manager of Data Engineering & Delivery (Data Science Production Engineering)
Role overview
Job description
This is an exciting opportunity to lead a Data Engineering & Delivery (DED) team at Natera, a global leader in precision medicine and genomics testing. As a Manager of the DED team inside our Data Science Production Engineering (DSPE) department, you will have the opportunity to work with Natera's diverse and ultra-large data sets (up to PB size), develop innovative solutions with the latest information and cloud technologies, and make real impact by providing timely, accurate, and robust data products and data delivery/automation systems to support Natera's Lab Operations and Genetic Counselor/Lab Director teams, and ultimately impact patients' medical outcomes. PRIMARY RESPONSIBILITIES: Leadership Lead a Data Engineering & Delivery (DED) team, collectively develop and maintain the data infrastructure, data ingestion solutions, ETL pipelines, robust data products, and data delivery so
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What they are looking for
Skills & requirements
Qualification
Masters degree in Statistics, Data Science, Bioinformatics, Computer Science, Mathematics, Management Science, Operational Research, or other related fields. Doctorate degrees are a plus. Minimal 5 years of relevant industry experience for candidates with a Master's Degree. Minimal 2 years of relevant industry experience for candidates with a Doctorate degree. Minimal 2 years of working experience in a highly regulated environment, e.g., CLIA and/or FDA compliant settings. Minimal 2 years of management experience leading a Data Engineering team, a Data Production/Delivery team, or a Data Analytics team, with demonstrable evidence of leadership and team management skills. KNOWLEDGE, SKILLS, AND ABILITIES: Strong proficiency in SQL and Python programming languages. Proficiency in R is a plus. Proficiency in data analysis and statistical techniques. Proficiency in data visualization tools (e.g., Tableau, Power BI, AWS QuickSight). Strong SQL skills in developing robust and maintainable queries to extract and/or aggregate data from complex data sources. Attention to detail and a commitment to data accuracy. Proficiency in building data products, e.g., data aggregation, extraction, tran
Department · Molecular Biology Informatics & Statistics
Hiring company
Natera
Dedicated to oncology, women’s health, and organ health. Natera’s cell-free DNA tests help protect health and inform more personalized decisions about care.
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