11h ago

Director, Study Start-Up

Watertown, MA

$195k-$275k / year

full-timeleadbiotech

๐Ÿ’ผ About This Role

You'll provide strategic and operational leadership for end-to-end study start-up activities across clinical programs, ensuring timely site activation. Your core impact will be driving first-patient-in targets and optimizing start-up processes. This role offers the opportunity to shape portfolio-level planning at a clinical-stage biotech.

๐ŸŽฏ What You'll Do

  • Lead study start-up strategy and execution across clinical programs
  • Manage regulatory and ethics submissions for country and site activation
  • Oversee site contract and budget negotiations with CROs
  • Proactively identify and mitigate risks to activation timelines
  • Develop and maintain start-up processes, systems, and tools

๐Ÿ“‹ Requirements

  • 10+ years in biotech/pharma with Clinical Operations project management
  • Proven track record in clinical trial execution and operational strategy
  • Strong understanding of ICH-GCP and regulatory compliance
  • Experience managing multiple projects concurrently

โœจ Nice to Have

  • Experience with targeted protein degradation or novel modalities
  • Background in immunology or oncology trials
  • Experience leading audits and inspections

๐ŸŽ Benefits & Perks

  • ๐Ÿ–๏ธ Unlimited PTO
  • ๐Ÿ’ฐ Equity participation
  • ๐Ÿฅ Comprehensive benefits
  • ๐Ÿ“ˆ Annual bonus eligibility

๐Ÿ“จ Hiring Process

Estimated timeline: 2-4 weeks ยท AI estimate

  1. 1Recruiter callยท 30 min
  2. 2Hiring manager interviewยท 45 min
  3. 3Panel interviewยท 60 min
  4. 4Offerยท 24-48 hours
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