Senior Director, Global Regulatory Affairs

Job description

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.