Senior Director, Medical Monitor & Safety Physician

Responsibilities

• Medical Monitoring & Clinical Trial Safety Oversight
• Serve as Medical Monitor for assigned clinical studies (Phase 1-3 and post marketing), ensuring subject safety and protocol adherence.
• Conduct timely medical review of eligibility questions, protocol deviations, dosing decisions, stopping rules, and emergent safety issues.
• Support investigator engagement, including safety related medical guidance and training on risk mitigation measures.
• Lead or support clinical event review (AEs, SAEs, AESIs), including assessment of seriousness, expectedness, relatedness, and follow up requirements.
• Provide medical input into informed consent forms, safety sections of protocols/IBs, and study level safety management plans.
• Safety Strategy & Pharmacovigilance Support
• Contribute to ongoing benefit risk assessments by integrating clinical, nonclinical, and real world safety information.
• Participate in safety review meetings and provide medical input into risk mitigation and communication strategies.
• Support development and maintenance of Risk Management Plans (RMPs), Safety Surveillance Plans, AESI definitions, and escalation pathways.
• Conduct medical review of case series, targeted analyses, and aggregate safety reports (e.g., DSUR, PBRER/PSUR).
• Support SUSAR/expedited reporting oversight in alignment with global reporting requirements and internal SOPs.
• Contribute to regulatory interactions, briefing documents, and inspection readiness activities.
• Data Review, Committees, and External Engagement
• Participate in DSMB/DMC interactions, including preparation of closed/open session materials and follow up actions.
• Support endpoint adjudication committees and safety adjudication processes.
• Contribute to investigator meetings, advisory boards, partner governance committees, and alliance management activities.
• Leadership & Cross‑Functional Collaboration
• Provide drug safety leadership within matrix teams, influencing alignment and execution across functions and vendors.
• Support departmental strategy implementation, operational improvements, and process enhancements.
• Quality, Compliance, and Inspection Readiness
• Ensure safety activities adhere to GxP, ICH guidelines, and applicable global regulations.
• Support SOP development, deviation investigations, CAPAs, and continuous improvement initiatives.
• Participate in audit/inspection preparation and serve as a knowledgeable medical safety representative.
• Education/Experience Requirements:
• MD or DO (or equivalent international medical degree).
• 8 years of experience in clinical development and/or pharmacovigilance, including medical monitoring responsibilities.
• Experience supporting interventional clinical trials (Phase 1-3 preferred).
• Strong understanding of global PV regulations and ICH guidelines.
• Demonstrated experience contributing to aggregate safety reporting (e.g., DSUR, PBRER/PSUR) and risk management planning (e.g., RMP).
• Ability to collaborate effectively in a fast paced environment and work with CROs/partners.
• Additional Skills/Experience:
• Experie

Benefits

Additional Information

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 . Position Summary: The Senior Director, Medical Monitor & Safety Physician is a clinical and safety leader responsible for providing medical monitoring and operational safety oversight of Nephrology and/or Metabolic clinical programs. This role delivers hands on medical monitoring, supports benefit risk evaluation, and contributes to safety strategy execution in close partnership with Clinical Development, Pharmacovigilance, Clinical Operations, Regulatory, Biostatistics, and other cross functional teams. This position functions as a key contributor to the Executive Director, ensuring high quality medical review, timely safety assessments, and consistent implementation of safety processes. The Sr. Director plays a critical role in safety decision support and program execution.

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