SOPHiA GENETICS

Senior Director, Clinical Application Product Management- East Coast- USA

Responsibilities:

  • Manage team of Clinical Application Product Managers (CAPMs) in different region(s)
  • Understand Sales team requirements to fulfill customers’ expectations and close opportunities
  • Develop positioning strategy of new and existing products
  • Constantly monitor the evolution of the clinical diagnostics ecosystem and competitive landscape
  •  Establish strong relationship with partners and regulatory bodies
  • Revise and specify requirements (“What”) of products and product-specific SOPHiA DDM® Features proposed by the team of Clinical Application Specialists
  • Responsible for coordinating product launches with cross-department stakeholders
  • Ensure trainings for SMEs are on products and Sophia DDM® Features so that in turn they can train the Sales team (“train the trainer”)
  • Review and create support content for internal use (pricing, quotations, PPT presentation)
  • Review and create content of public marketing collaterals (fact sheets, flyers, white papers, web site announcements)
  • Measure and report Sales and Revenue performance of products
  • Represent Sophia Genetics as product expert and senior management
  • Conduct market surveillance and complaints analysis
  • Oversee CAPMs performance and activities, provide feedback, support and coaching

Requirements:

  •  10+ in diagnostics, biotech, pharma industry with hands on experience in regulatory affairs highly preferred
  •  Masters, PhD or other advanced degree in Biological Sciences or equivalent field of study
  • Advanced working knowledge of Genomics, biological reagent, instruments (especially NGS), software and assay workflow, as well as good understand of bioinformatics
  •  Experience in CLIA/CAP accreditation, ISO 13485 and FDA QSR quality management system requirements, as well as IVD products
  •  Knowledge of managing Clinical monitoring process and administration of Clinical trials, and oversight adherence to SOPs, GCP and FDA regulation a plus
  •  Focus on Cancer & Oncology or Hereditary disorders
  •  Strong Product Life Cycle management and product development experience with regulatory intuition
  • Experience in Market Research and strategic market development
  • Proven track record of launching products integrating NCCN, ASCO, AMP, ACMG guidelines
  • Experience in strategic product development for FDA submission, advanced knowledge of submission pathways, hands-on experience
  • Good understanding of the US Healthcare reimbursement systems
  • Excellent managemant and communication skills, facility to explain complex scientific concepts

Location: Boston, USA