Senior Director, Global Regulatory Affairs
Janux TherapeuticsOncology Therapeutics company
San Diego, United StatesDirector
Avalon Ventures
OrbiMed
RA Capital Management
Bregua
Correlation Ventures
BVF Partners
Leadership & General Management
About the role
TL;DR
Provide strategic regulatory leadership across Janux’s clinical-stage oncology pipeline.
- •The Senior Director, Global Regulatory Affairs will provide strategic regulatory leadership across Janux’s clinical-stage oncology pipeline.
- •Key Responsibilities Lead the development and execution of global regulatory strategies across early
- •and late-stage programs.
- •Translate strategic plans into functional and operational regulatory execution across cross-functional teams.
- •Serve as the regulatory lead on cross-functional program teams, driving alignment and enabling timely, high-quality decision-making.
- •Influence key program decisions, including trial design, dose escalation strategies, endpoints, and development pathways based on regulatory considerations.
- •Lead regulatory strategy for early clinical development (Phase 1/2), including IND/CTA planning, protocol input, and health authority engagement.
- •Requirements BS in life sciences or related field required; advanced degree (PhD, PharmD, MD, or equivalent) preferred.
- •Minimum of 12–15+ years of regulatory affairs experience in biotechnology or pharmaceutical industry.
- •Experience spanning early clinical development (Phase 1/2) through later-stage development global regulatory strategy for oncology or related therapeutic areas.
- •Direct experience with IND and global CTA submissions, including EU CTR.
- •Proven track record of leading health authority interactions (FDA and ex-US) and influencing development strategy.
Required skills
Strategic PlanningCross-functional Leadership
Domain expertise
healthcare