Executive Director, Medical Monitor and Safety Physician

Department:

106750 Clinical Development

Location:

San Diego, USA- Remote

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.

At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because we are making a difference. We are passionate about what we do.

We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission – to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.

At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.

Role Summary

The Executive Director, Medical Monitor & Safety Physician is a senior clinical and safety leader responsible for medical monitoring and end-to-end safety oversight across one or more development programs and/or therapeutic areas. This role serves as the accountable safety physician for clinical trials and senior medical authority for safety across programs, with responsibility for benefit–risk positioning and safety-related decision-making.

The incumbent will partner closely with Clinical Development, Pharmacovigilance, Clinical Operations, Regulatory, Biostatistics, Medical Affairs, and Quality to ensure patient safety, regulatory compliance, and scientifically sound benefit-risk evaluation throughout the product lifecycle. This role holds delegated authority to escalate and resolve significant safety issues impacting program development and regulatory strategy.

This position is hands-on and strategic: you will provide real-time medical monitoring support and be a key contributor to safety deliverables (e.g., DSUR, PBRER/PSUR, RMP) as well as represent projects and programs in internal and external forums, including interactions with regulators, DSMBs, investigators, and partners.

Key Responsibilities

Medical Monitoring & Clinical Trial Safety Oversight (Clinical Development)

• Serve as the lead Medical Monitor for assigned clinical studies (Phase 1–3 and/or post-marketing), ensuring subject safety and protocol compliance.

• Provide timely medical review of critical eligibility questions, protocol deviations impacting safety, dosing decisions, stopping rules, and emergent safety issues.

• Support site and investigator engagement, including medical support for safety-related questions and training on risk mitigation measures.

• Lead and/or oversee clinical event review (AEs, SAEs, AESIs), including assessment of seriousness, expectedness, relatedness, and follow-up requirements.

• Ensure medical input into informed consent language, safety sections of protocols/IBs, and trial-level safety management plans.

Safety Strategy & Medical Oversight (Drug Safety & Pharmacovigilance)

• Lead ongoing benefit–risk assessment for assigned products, integrating clinical, nonclinical, and real-world safety information and serve as the accountable medical authority for benefit–risk determinations within assigned programs.

• Participate in safety review meetings and provide medical oversight as needed and drive decision-making on risk controls and communications. Serve as a core decision-making member of safety governance forums with authority to recommend escalation and risk mitigation actions.

• Participate in the development and maintenance of Risk Management Plans (RMPs), Safety Surveillance Plans (including AESIs, thresholds, and escalation pathways). Provide final medical review and approval of program-level safety surveillance strategies.

• Provide Medical oversight of signal detection activities from clinical trials, literature, spontaneous reports, and partner data.

• Provide medical reviews of case series targeted analyses, aggregate safety data reports (e.g., DSUR, PBRER/PSUR) and other periodic safety deliverables and serve as accountable medical signatory for such reports as applicable.

• Support SUSAR/expedited reporting oversight, ensuring alignment with global reporting requirements and company SOPs.

• Prepare and participate in regulatory interactions (briefing documents, meeting participation, in