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← Kailera Therapeutics, Inc.

Associate Director, Device Engineering

Kailera Therapeutics, Inc.
Location
US-Remote
Posted
1 month ago
Department
Drug Product
What they actually want (must-haves)
  • Minimum of 10+ years of experience in medical device or combination product development
  • At least 3 years in a team leadership role
  • Proven experience with autoinjector, pre-filled syringe, or multidose pen development and launch
  • Experience authoring clinical and commercial regulatory submissions
  • Deep understanding of design controls, design verification, test method development and validation, risk management, human factors, and design transfer
  • Strong knowledge of applicable regulatory standards and guidance documents
Nice to have
  • Experience working in a regulated pharmaceutical or biotech environment
  • Familiarity with combination product regulations (21 CFR Part 4)
  • Experience with supplier management of external development, testing, and manufacturing partners
  • PMP certification or formal project management training
What the job really is

The Associate Director of Device Engineering at Kailera will lead the development and launch of drug-device combination products, focusing on autoinjectors, pre-filled syringes, and multidose pens. This role involves cross-functional collaboration to ensure product development meets patient needs and regulatory standards, overseeing project plans, compliance, risk management, and design transfer to manufacturing.

Benefits
  • Salary range of $159,000 — $195,000 USD
  • Comprehensive health coverage
  • Flexible time off
  • Paid holidays
  • Year-end shutdown
  • Monthly wellness stipend
Things to weigh
  • Remote work is possible but requires onsite presence at a hub one week every other month
  • The role involves significant regulatory compliance responsibilities which may be complex
  • No specific mention of team size or structure for leadership context
Job score3.6/5
Benefits5/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency0/5

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