Serve as the technical and development lead for next generation sequencing (NGS) based companion diagnostic programs. The candidate is responsible to work with internal and external cross-functional teams, to establish and drive the technical strategies and approaches for diagnostic programs at Novartis Oncology Precision Medicine (OPM). The candidate is responsible for overseeing internal NGS based feasibility studies as well as the technical and development activities at the external partner(s) and ensure the milestones are defined and achieved to meet program objectives.
Program Leader and subject matter expert for NGS feasibility and IVD product development; work with cross functional teams (internal and external teams) to develop and execute project plans; oversee the development activities, deliverables, and milestones of external partners; and drive the success of the programs for Novartis OPM.
• Drives the implementation of NGS technology within Novartis OPM.
• Ensures efficient operation of the NGS platform, including sample preparation, library construction, template preparation, sequencing, and other genomic applications, data analysis and bioinformatics.
• Provides state of the art core services and guidance to OPM on experimental design and best method or technology to address a particular scientific question.
• Develops bioinformatics analysis processes in collaboration with Novartis internal and external multidisciplinary teams.
• Proactively monitors technological developments and new applications.
• Defines NGS Diagnostic Development strategy on the program and provides day to day technical oversight of Diagnostic Development Program as applicable.
• Assumes technical leadership role, work with internal and external partners to develop and execute technical strategies, identify technical risks, develop and execute project plan(s) and risk mitigation plan(s) to achieve program objectives.
• Represents OPM on companion diagnostics programs for NGS IVD product development with external partners.
• Oversees the external partners’ key development activities and deliverables, including any needed due diligence, and drive technical discussions and decisions and ensure the milestones are achieved in accordance to project timelines and budget.
• Accountable for effective execution of project plan(s), effective utilization of resources in alignment with the different OPM programs and on-time delivery of the major deliverables.
• Responsible for performance and talent management of direct reports
EEO Statement 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.
PhD (with minimum of 5+ years of experience), or MS (with minimum of 7+ years of experience) or BS (with minimum 10+ years of experience) in a relevant scientific field, such as biochemistry and/or molecular biology.
In-depth knowledge of NGS assays and platform technologies. Experience in handling NGS data with participation in NGS projects and familiarity with NGS software analysis packages is also desired.
Technical expertise in other technologies (sample preparation, ctDNA and/or dPCR/PCR) is also highly valued.
Excellent writing and verbal communication and presentation skills are essential.
4+ years of management and leadership experience are required. Strong management and leadership skills, especially for influencing, conflict management and team building, with proven ability to direct and lead functional (assay development) teams and to collaborate effectively with internal and external stake holders in a highly dynamic environment.
Experience working with external assay development teams is highly desirable.
Experience in developing IVD regulated diagnostics (either 510K or PMA) and drafting/reviewing/editing documents required for product development, regulatory submission and quality compliance is highly desirable.
Ability to perform under pressure and adapt to changes (e.g., priori-ties and timelines) is essential.