🛠 Tech Stack

💼 About This Role

You'll define and lead the end-to-end global regulatory diagnostic strategy for our portfolio of RAS-targeted oncology therapies. You'll ensure synchronized drug–diagnostic co-development from discovery through global registration, making Regulatory Affairs a strategic partner across R&D and commercial teams. This role offers the opportunity to shape CDx innovation at a late-stage clinical oncology company.

🎯 What You'll Do

• Define and execute global CDx regulatory strategy aligned with pipeline.
• Build and lead a high-performing global regulatory CDx organization.
• Own and manage global regulatory CDx operating budget.
• Align CDx development timelines with clinical and regulatory milestones.

📋 Requirements

• Advanced degree in Molecular Biology, Pathology, Genetics, or related discipline.
• 14+ years in pharmaceutical, biotech, or diagnostics organizations.
• 10+ years leading companion diagnostics or biomarker-driven programs.
• Proven success with FDA and global CDx submissions including PMA/IDE and IVDR.

✨ Nice to Have

• Experience supporting registrational oncology trials with companion diagnostics.
• Track record of successful drug–diagnostic co-launches.
• Established external network with diagnostic manufacturers, CROs, and global regulators.

🎁 Benefits & Perks

• 💰 Competitive base pay ($244,000–$305,000).
• 📈 Robust equity awards.
• 🏥 Strong benefits package.
• 📚 Significant learning and development opportunities.

📨 Hiring Process

Estimated timeline: 3-6 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 45 min
3. 3Panel Interview· 90 min
4. 4Offer· 15 min