Adaptive Biotechnologies Corp.

Every immune system has a story to tell; the key is knowing how to listen.

Senior Director, Clinical Product Development

DirectorDirectorFull TimeRemoteTeam 501-1,000Since 2009H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

7 days ago

Salary

$206.4K - $309.6K / year

Postgraduate Degree10 yrs expEnglish

Job Description

• Responsible for managing a team that is responsible for clinical product development activities, which could include technical feasibility, methods development, assay development, design risk management, bioinformatics and software algorithm development, verification and validation (V&V) studies, new indications, support IST data generation, and serve as the technical representative in customer facing meetings for MRD business. • Collaborate with other departments, including Research, Technical Operations, Medical Affairs, Software, PMO, Integrated Supply Chain, Quality & Regulatory, Clinical Lab Director, Legal, Finance, Equipment Engineering, and Commercial to achieve the goal of developing assay prototypes to commercial products. • Communicates plans, proposes short- and long-term strategies, timelines, and results to executive level and with stakeholders across the organization. • Guides decision-making and scientific mentorship • Manages team members performance and career development • Seen as Adaptive’s SME regarding product development work, which includes strong understanding and contributes to results analysis of NGS immunosequencing data and complex statistical analyses. • Write and edit study reports, with analysis support from technical experts from the larger team. • All other duties as assigned.

Job Requirements

  • PhD (or advanced degree) in molecular genetics, immunology, bioengineering or related field
  • 10+ years of experience in a diagnostic, medical device or life sciences company
  • Experience managing subordinate managers
  • Minimum of 5 years of Product Development Process (PDP) experience with regulated IVD product development under design control, including verification and validation activities
  • prior experience with NGS diagnostic product commercialization strongly preferred
  • Demonstrated experience in ISO, CLIA, CAP, CLEP, FDA, IVDR, GxP or equivalent regulatory compliance requirements required
  • Familiarity with the application of basic statistical analyses required
  • Excellent technical scientific writing, communication, and organizational skills, with significant attention to detail
  • Experience in hematology, oncology, immunology with NGS technology is preferred
  • Prior experience with JMP, R or other statistical analysis software preferred.

Benefits

  • equity grant
  • bonus eligible

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