11h ago
Director, Study Start-Up
Watertown, MA
$195k-$275k / year
full-timeleadbiotech
๐ผ 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.
๐ฏ 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
๐ 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
โจ Nice to Have
- Experience with targeted protein degradation or novel modalities
- Background in immunology or oncology trials
- Experience leading audits and inspections
๐ Benefits & Perks
- ๐๏ธ Unlimited PTO
- ๐ฐ Equity participation
- ๐ฅ Comprehensive benefits
- ๐ Annual bonus eligibility
๐จ Hiring Process
Estimated timeline: 2-4 weeks ยท AI estimate
- 1Recruiter callยท 30 min
- 2Hiring manager interviewยท 45 min
- 3Panel interviewยท 60 min
- 4Offerยท 24-48 hours
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