Janux Therapeutics

Senior Director, Global Regulatory Affairs

San Diego, CA · Director · Full-time

Work authorization required$240k-$275kDetected 165 days ago

Project ManagementFDA RegulatoryLeadershipCommunicationMentoringOrganizational SkillsRegulatory Affairs

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.

Lead the development and execution of global regulatory strategies across early- and late-stage programs, ensuring alignment with overall portfolio objectives.
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.
Identify regulatory risks and lead mitigation strategies in the context of incomplete or evolving data.
Drive alignment across functions in situations with ambiguity, competing priorities, or limited precedent.
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.

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.
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.
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.

Lead regulatory strategy for early clinical development (Phase 1/2), including IND/CTA planning, protocol input, and health authority engagement.

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.
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.

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

This listing is sourced directly from Janux Therapeutics's careers page and normalized into a canonical job model.