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Sr. Product Manager, IVD

Natick, MA | Full-time      

Job purpose:

Support Pillar’s growth by joining our product management team to oversee a growing product portfolio.  The Sr. Product Manager – IVD will take ownership of Pillar’s global IVD product portfolio, lead strategic development of future initiatives, and be the interface between R&D and the commercial operation. The position will provide significant input into product-related business decisions and resource planning along with playing a critical role in key initiatives, often leading project teams.  The Product Manager will report to the Associate Director of Product Management.

Duties and responsibilities

  • Lead global launch of Pillar’s first IVD product in the US (FDA PMA) and Europe and other countries that recognize CE IVD
  • Manage collaboration with partners at launch
  • Support regulatory and in-country marketing efforts in CE IVD regions
  • Determine and communicate customer needs for multiple future IVDs
    • Partner with the commercial organization to determine customer needs via discussions with current and potential customers and formal market research
    • Translate customer needs into product requirements for R&D (software and chemistry). Manage the development of user requirements, including the planning, execution and reporting of product validation activities
  • Productization
    • Ownership of product positioning, messaging, and value proposition
    • Mange product launches with commercial team and provide product training
    • Ensure all documentation is ready at launch
    • Partner with marketing to develop product sheets and other technical data
    • Co-ordinate packaging and inventory management with Operations
  • Communicate with KOLs, clinical collaborators, and potential future customers to identify areas of commercial opportunity

Education:

    • BS in pre-med, biology, clinical laboratory medicine, chemistry, bioinformatics, or related scientific field required.  Advanced medical/scientific degree (MD, DO, PA, NP, nursing, MS, Ph. D or similar) and/or MBA preferred

Experience, Knowledge, Skills and Abilities:

  • 3+ years of Product Management experience with FDA and CE IVD regulated products
  • 5+ years’ product management experience in diagnostics, pharmaceuticals, biotechnology, or medical device preferred
  • Background in identifying and expressing clinical utility for the oncology testing market
  • Experience with NGS including bioinformatics preferred
  • Understanding of clinical oncology, pathology, genomics, molecular biology, and sequencing applications is essential
  • Demonstrated success managing complex products/projects with minimal oversight
  • Ability to distill complex technical data into actionable messages for commercial organization
  • Ability to work with all levels of the organization (Sr. management, R&D, commercial, QA/RA, and operations)
  • Ability to learn and understand both the technical and commercial aspects of the NGS business
  • Entrepreneurial mindset. A “do whatever it takes” mentality not a “that’s not my job” attitude
  • Ability and willingness to travel domestically and internationally when necessary

 

We offer a competitive compensation and benefits package that includes medical and dental insurance, paid vacation, 401(k), and more. For more information visit www.pillar-biosciences.com. Pillar Biosciences Inc. is an Equal Opportunity Employer.

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