💼 About This Role

You'll provide strategic leadership and operational oversight for clinical trials at a clinical-stage biotechnology company. You'll drive cross-functional study teams and manage CROs to ensure timely, budget-compliant, and high-quality trial execution. This role offers the opportunity to lead in cell therapy and autoimmune disease studies.

🎯 What You'll Do

• Lead cross-functional clinical study teams to meet timelines and budgets
• Direct CRO and vendor selection, negotiation, and oversight
• Oversee development of study documents and regulatory submissions
• Ensure Trial Master File and inspection readiness

📋 Requirements

• 10+ years progressive clinical operations experience
• 5+ years direct sponsor clinical study management
• Bachelor's degree in scientific or healthcare discipline
• Working knowledge of ICH/GCP and FDA regulations

✨ Nice to Have

• Cell/gene therapy clinical trial experience
• Experience in autoimmune indications (MS, IBD)

🎁 Benefits & Perks

• 🏖️ Unlimited PTO
• 💰 Competitive salary
• 📈 Equity
• 🏥 Health insurance

📨 Hiring Process

Estimated timeline: 3-5 weeks · AI estimate

1. 1Recruiter phone screen· 30 min
2. 2Hiring manager interview· 60 min
3. 3Panel interview· 90 min