Director, Pharmacovigilance bei Januxrx

The Director of Pharmacovigilance will lead all safety-related activities across Janux’s clinical development programs. This individual will ensure the safety of patients participating in clinical trials and the integrity of Janux’s safety data. This role combines strategic leadership with hands-on execution, ensuring compliance with global regulatory requirements and the proactive integration of safety into drug development. The Director will also serve as a key liaison with regulatory authorities and internal stakeholders, driving a culture of safety and continuous improvement.



ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

Develop and execute pharmacovigilance strategies in alignment with Janux’s clinical and regulatory goals.

Represent Janux in safety-related interactions with global health authorities (e.g., FDA, EMA, APAC).

Lead the development and implementation of safety management plans, risk management plans (RMPs), and signal detection strategies.

Ensure safety is proactively integrated into clinical development and decision-making processes.

Oversee the collection, evaluation, and reporting of adverse events (AEs) and serious adverse events (SAEs) from clinical trials.

Manage external PV vendors and ensure timely, high-quality execution of contracted activities.

Maintain a central repository and program plan for all PV activities and deliverables.

Ensure readiness and execution of safety procedures in response to emerging safety concerns.

Author and review PV-related documents including DSURs, SMPs, RMPs, RSIs, and safety sections of clinical protocols and study reports.

Ensure compliance with global PV regulations (FDA, EMA, APAC, ICH, GVP) and internal SOPs.

Monitor and ensure adherence to PV agreements and safety data exchange agreements (SDEAs) with partners.

Support internal audits and regulatory inspections; conduct root cause analyses and implement CAPAs as needed.

Serve as the safety representative in cross-functional teams, including clinical, regulatory, and medical affairs.

Educate internal teams on evolving safety regulations and best practices.

Lead or contribute to internal safety review meetings, DSMBs, and safety advisory committees.

Other duties as deemed necessary

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES

Graduate-level degree in life sciences, RN, or equivalent health-related training; MD or PharmD preferred.

8+ years of pharmacovigilance experience in the biotech or pharmaceutical industry, including proven leadership roles.

Strong knowledge of global PV regulations (FDA, EMA, APAC, ICH, GVP).

Experience in signal management, safety data interpretation, and regulatory reporting.

Oncology and autoimmune experience will be prioritized in this role.

MPH or pharmacoepidemiology training desirable.

Demonstrated ability to lead cross-functional safety initiatives and influence decision-making.

Excellent communication, analytical, and organizational skills.

Proficiency in safety databases (e.g., Argus, ARISg) and MedDRA coding.

Ability to travel domestically and internationally as needed.

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