💼 About This Role

You'll lead clinical study design and execution for an early cancer detection company using AI and whole-genome sequencing. You'll shape a five-year clinical development strategy and interact with the FDA on IVD product approvals. Your work will directly impact lung cancer detection in high-risk individuals through innovative AI-enabled trial recruitment.

🎯 What You'll Do

• Design and execute clinical studies for product claims and regulatory approval
• Establish a five-year clinical development strategy based on evidence gaps
• Manage clinical operations, CROs, site selection, and patient enrollment
• Liaise with R&D and PIs to develop sub-studies advancing the pipeline

📋 Requirements

• PhD or MD in physical/natural sciences
• 10+ years leading clinical studies in pharma or diagnostics
• 3-5 years in IVD diagnostics development
• Knowledge of regulatory standards like ICH GCP and ISO 13485

✨ Nice to Have

• Familiarity with AI approaches in clinical trials (NLP, digital twins)
• Experience with international data standards such as FAIR principles

🎁 Benefits & Perks

• 🏥 Health and wellness benefits likely included
• 💰 Competitive compensation with equity
• 🧪 Cutting-edge science environment
• 🏢 Hybrid work flexibility
• 📈 Leadership growth opportunities