About the role
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.
Job Type: Full-time
Benefits:
· Annual bonus program
· Incentive stock option plan
· 401k plan with flat non-elective employer contribution
· Comprehensive medical insurance with 90-100% employer-paid premiums
· Dental and vision insurance
· HSA, FSA, and supplemental insurance plans (life, disability, accident, critical illness, hospital indemnity)
· Unlimited PTO
· Generous holiday schedule; includes summer and winter company shutdown
· Relocation assistance
Schedule:
· Monday to Friday
Work authorization:
· United States (Required)
Additional Compensation:
· Annual targeted bonus %
Work Location:
· Hybrid preferred in San Diego office. Remote permitted upon approval, with ability to travel up to 25% for meetings or site visits as required.
EQUAL OPPORTUNITY EMPLOYER:
Janux Therapeutics, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.
Text as published by Janux Therapeutics. We don't edit postings; apply and ask questions on the employer's site.