The Senior Director, Global Regulatory Affairs will provide strategic regulatory leadership across Janux’s clinical-stage oncology pipeline, supporting programs from early development through registration. This individual will lead global regulatory strategy for one or more programs while influencing and partnering closely with cross-functional stakeholders to shape development plans and ensuring alignment across functions in a dynamic, fast-paced environment.

 

This role requires a hands-on regulatory leader with deep experience in early clinical development (Phase 1/2), coordinating multiple parallel regulatory initiatives, strong health authority interaction experience, the ability to exercise judgment with decisions that have long-term impact on regulatory function success, and guide teams through ambiguity and evolving data.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

Lead the development and execution of global regulatory strategies across early- and late-stage programs, ensuring alignment with overall portfolio objectives.

Translate strategic plans into functional and operational regulatory execution across cross-functional teams including Clinical, CMC, Biometrics, and Translational Sciences.

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.

Provide regulatory leadership for global clinical trial strategy, including EU Clinical Trial Regulation (CTR) and CTA submissions.

Serve as the primary regulatory contact with global health authorities (e.g., FDA, EMA, Health Canada, MHRA), leading critical interactions including meeting strategy, briefing documents, negotiations, and follow-up activities.

Evaluate and advise on regulatory pathways, including expedited programs (e.g., Fast Track, Breakthrough Therapy, Orphan Drug) and regional strategies.

Assess emerging clinical and nonclinical data and translate insights into adaptive regulatory strategies, adjusting development plans as needed.

Identify regulatory risks and lead mitigation strategies in the context of incomplete or evolving data.

Operate effectively in complex environments, working with abstract concepts and cross-functional inputs to shape regulatory direction.

Drive alignment across functions in situations with ambiguity, competing priorities, or limited precedent.

Exercise a high degree of judgment; decisions carry long-term impact on regulatory function success and program advancement.

Negotiate critical regulatory and strategic matters with senior and executive-level stakeholders internally and externally.

Contribute to the development and continuous improvement of regulatory processes, systems, and best practices to support organizational growth.

Collaborate with internal teams and external partners to ensure high-quality and timely execution of regulatory deliverables.

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES

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.

Ability to operate effectively in environments with uncertainty, shifting priorities, and incomplete data.

Demonstrated ability to work with complex and abstract problems across multiple functional areas.

Strong leadership skills, including experience mentoring, developing, and influencing teams.

Ability to lead through influence across functions without direct authority.

Experience managing regulatory risk and translating requirements into practical development strategies.

Excellent communication skills, with the ability to clearly articulate regulatory strategy to both technical and non-technical stakeholders.

Strong executive presence with the ability to influence and negotiate at senior levels internally and externally.

Strong project management and organizational skills in a fast-paced environment.