💼 About This Role

You'll oversee Phase 4 and post-marketing clinical studies as the Clinical Operations sponsor representative for a late-stage oncology company. You'll ensure compliance with FDA regulations, ICH guidelines, and GCP while managing vendor oversight and cross-functional partnerships. This role offers a unique chance to lead post-approval research in a rapidly growing biotech.

🎯 What You'll Do

• Serve as Clinical Operations sponsor lead for Phase 4 and post-marketing studies
• Oversee vendor-managed late-phase trials ensuring regulatory compliance
• Partner with Regulatory, Medical Affairs, and Safety for post-marketing commitments
• Manage drug supply, financial oversight, and risk tracking for assigned programs

📋 Requirements

• BS or MS degree with 10+ years of clinical operations experience in pharma/biotech
• Direct experience supporting Phase 4 or post-marketing clinical research
• Strong understanding of sponsor responsibilities under FDA regulations and GCP
• Experience overseeing external vendors delivering regulated clinical programs

✨ Nice to Have

• Experience supporting global or multi-regional late-phase clinical studies
• Familiarity with Quality Technical Agreements and Safety Data Exchange Agreements
• Oncology clinical research experience

🎁 Benefits & Perks

• 🏥 Comprehensive health insurance
• 💰 Competitive 401(k) matching
• 🌴 Paid time off
• 📚 Professional development opportunities
• 🏢 Hybrid work model

📨 Hiring Process

Estimated timeline: 3-5 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 60 min
3. 3Panel Interview· 90 min