1d ago
Head of Clinical Development
Boston, MA
✨ $250k-$350k / yearest.
full-timeseniorbiotech
💼 About This Role
You'll lead clinical research and development for an AI-driven nonprofit repurposing existing drugs to treat unmet needs. You'll serve as both strategic architect and working clinical lead on priority programs, managing trials, registries, and regulatory compliance. This role offers the chance to drive high-impact drug repurposing with open-source AI and philanthropic backing.
🎯 What You'll Do
- Design and author clinical trial protocols, statistical plans, and study reports.
- Serve as medical monitor on IND-holding trials and oversee safety reporting.
- Manage IRB submissions, SAE adjudication, and REMS program compliance.
- Collaborate with computational teams to translate AI hypotheses into clinical programs.
- Lead regulatory strategy, QMS maintenance, and sponsor oversight of CROs.
📋 Requirements
- M.D. or equivalent medical degree with clinical development experience in biotech/pharma.
- 5+ years experience as a medical monitor or clinical lead on IND-holding trials.
- Deep knowledge of FDA 21 CFR Part 312, ICH E6(R3), and ICH E9 guidelines.
- Experience with drug repurposing or rare disease clinical trials.
✨ Nice to Have
- Experience with investigator-sponsored trials and patient registries.
- Familiarity with AI/ML applications in clinical development.
- Experience at a nonprofit or mission-driven organization.
🎁 Benefits & Perks
- 🏖️ Unlimited PTO
- 🏥 Health, dental, and vision insurance
- 📈 401(k) matching
- 💡 Mission-driven work with high social impact
📨 Hiring Process
Estimated timeline: 3-5 weeks · AI estimate
- 1Recruiter screen· 30 min
- 2Hiring manager interview· 45 min
- 3Technical presentation· 60 min
- 4Panel interview· 60 min
- 5Final executive interview· 45 min
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