Associate Director, Clinical Product Development

Adaptive Biotechnologies

Seattle, United States
Base: $144,600 - $217,000; bonus/equity: equity gr...
On-site
Clinical diagnostic assays development
Assay development and validation
Design history file (dhf) compliance
Lead a multi-functional team of scientists responsible for the development and validation of clinical diagnostic assays from Concept through Launch

Job Summary

  • Lead a multi-functional team of scientists responsible for the development and validation of clinical diagnostic assays from Concept through Launch.
  • Oversee development of analytical validation plans, and support clinical validation plans, for new assays and product extensions.
  • Coach team members on Design History File (DHF) and Risk Management documentation, ensuring compliance with applicable regulations.

Matching Summary

Lead a multi-functional team of scientists responsible for the development and validation of clinical diagnostic assays from Concept through Launch.

Salary

Base: $144,600 - $217,000; Bonus/Equity: equity grant, bonus eligible; Benefits: Not specified

Skills & Requirements

Must-have

  • Clinical diagnostic assays development
  • Assay development and validation
  • Design History File (DHF) compliance
  • Risk Management documentation
  • Cross-functional team leadership

Nice-to-have

  • Immune system medicine
  • Product pipeline strategy
  • Belonging and respect environment
  • Performance excellence and accountability

Key Requirements

  • PhD with 8+ years experience
  • MS with 10+ years experience
  • BS with 12+ years experience
  • 4+ years in diagnostic, medical device or life sciences
  • 4+ years supervisory experience

Work Rights

Not specified

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