Description

You will lead global regulatory strategy for early-stage oncology programs from pre-IND through Phase 2, shaping innovative pathways to accelerate development while positioning assets for success. This role also involves building scalable regulatory processes and leading cross-functional portfolio efforts.

Requirements

• 8+ years of regulatory experience in biotech or pharmaceutical industry
• Significant experience leading early development programs (IND-enabling through Phase 2)
• Demonstrated success leading global health authority interactions
• Experience building or scaling regulatory processes in a growing organization
• Ability to influence and partner with senior stakeholders

Responsibilities

• Lead global regulatory strategy from candidate selection through end-of-Phase 2
• Shape early clinical development strategy including dose-finding and indication selection
• Oversee global regulatory interactions and briefing documents (Pre-IND, IND, Scientific Advice, etc.)
• Design and implement fit-for-purpose early development regulatory processes
• Serve as regulatory representative in early development governance forums