Senior Director, Global Regulatory Affairs

@ Janux Therapeutics
Janux Therapeuticsjanuxtherapeutics.com

Senior Director, Global Regulatory Affairs

Posted 5 months ago

This job is still taking applications, but it's been up a while.

About the job

Janux Therapeutics develops innovative biopharmaceuticals, focusing on cancer treatments. The role involves leading global regulatory strategies, submissions, and ensuring compliance across programs in a dynamic, fast-paced environment.

Requirements

  • 10+ years regulatory experience
  • Knowledge of biologics development
  • Proven regulatory submission success
  • Experience with FDA, EMA, MHRA
  • Strong leadership and communication

Qualifications

  • BS in life sciences required
  • MS, PhD, PharmD preferred
  • Experience with biotech industry
  • Ability to lead cross-functional teams
  • Excellent verbal and written skills

Full 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.


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.

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