Head of Regulatory Affairs (Oncology)

📍 Bay Area, CA (Hybrid)

About the Company
We're partnering with a clinical-stage biotech operating in stealth mode, focused on advancing innovative therapies in oncology. The company is backed by a strong investor syndicate and is entering a critical phase of growth with promising early clinical data and a clear path toward later-stage development.

The Opportunity
This is a foundational leadership hire with direct exposure to executive leadership and the Board. You'll own the global regulatory strategy while staying hands-on-shaping development plans, driving submissions, and building the regulatory function from the ground up.

What You'll Do

• Lead global regulatory strategy across clinical-stage oncology programs (Phase I-III)
• Serve as the primary point of contact with FDA and global health authorities
• Partner closely with executive leadership on development and filing strategy
• Drive INDs, submissions, and regulatory milestones
• Build and scale regulatory infrastructure, processes, and team over time

What We're Looking For

• Proven regulatory leadership experience in oncology (hematology a plus)
• Depth across early through late-stage development
• Strong track record of FDA interaction and regulatory strategy ownership
• Ability to operate both strategically and tactically in a lean environment
• Executive presence with strong cross-functional communication skills

Why This Role

• High-visibility role with direct impact on company trajectory
• Opportunity to shape regulatory strategy at a pivotal stage
• Lean, collaborative team with strong scientific foundation
• Competitive compensation + meaningful equity