Senior Director, Medical Monitor & Safety Physician
Travere Therapeutics
August 17, 2026
Remote friendly (United States)
United States
Medical Affairs
Position Summary:
The Senior Director, Medical Monitor & Safety Physician is responsible for providing medical monitoring and operational safety oversight of Nephrology and/or Metabolic clinical programs. Delivers hands-on medical monitoring, supports benefit-risk evaluation, and contributes to safety strategy execution with cross-functional teams.
Responsibilities:
- Serve as Medical Monitor for assigned Phase 1–3 and post-marketing studies; ensure subject safety and protocol adherence.
- Review eligibility questions, protocol deviations, dosing decisions, stopping rules, and emergent safety issues.
- Provide safety medical guidance to investigators, including risk-mitigation training.
- Lead/support review of AEs/SAEs/AESIs (seriousness, expectedness, relatedness, follow-up).
- Provide medical input into informed consent forms, safety sections of protocols/IBs, and study safety management plans.
- Contribute to benefit-risk assessments; participate in safety review meetings and risk mitigation/communication.
- Support RMPs, Safety Surveillance Plans, AESI definitions, and escalation pathways.
- Review case series/targeted analyses and aggregate safety reports (e.g., DSUR, PBRER/PSUR); support SUSAR/expedited reporting oversight.
- Support regulatory interactions, briefing documents, and inspection readiness.
- Participate in DSMB/DMC interactions; support endpoint and safety adjudication.
- Provide drug safety leadership in matrix teams; support strategy implementation and process improvements.
- Ensure activities comply with GxP, ICH, and global regulations; support SOPs, deviations, CAPAs, and audits/inspections.
Education/Experience Requirements:
- MD or DO (or equivalent international medical degree).
- 8+ years in clinical development and/or pharmacovigilance, including medical monitoring.
- Interventional trial experience (Phase 1–3 preferred).
- Strong knowledge of global PV regulations and ICH.
- Experience with aggregate safety reporting (e.g., DSUR, PBRER/PSUR) and risk management planning (e.g., RMP).
Additional Skills/Experience:
- Early development/first-in-human/dose escalation (incl. DLT review); labeling/CCDS and post-marketing safety.
- Global filings and interactions with FDA/EMA/health authorities.
- Strong clinical judgment, communication, and ability to translate safety data into recommendations.
- Travel domestically/internationally up to 20–25%.
Benefits:
- Premium health, financial, work-life and well-being offerings; wellness and employee support programs; life insurance; disability; retirement with employer match; generous paid time off.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.
The Senior Director, Medical Monitor & Safety Physician is responsible for providing medical monitoring and operational safety oversight of Nephrology and/or Metabolic clinical programs. Delivers hands-on medical monitoring, supports benefit-risk evaluation, and contributes to safety strategy execution with cross-functional teams.
Responsibilities:
- Serve as Medical Monitor for assigned Phase 1–3 and post-marketing studies; ensure subject safety and protocol adherence.
- Review eligibility questions, protocol deviations, dosing decisions, stopping rules, and emergent safety issues.
- Provide safety medical guidance to investigators, including risk-mitigation training.
- Lead/support review of AEs/SAEs/AESIs (seriousness, expectedness, relatedness, follow-up).
- Provide medical input into informed consent forms, safety sections of protocols/IBs, and study safety management plans.
- Contribute to benefit-risk assessments; participate in safety review meetings and risk mitigation/communication.
- Support RMPs, Safety Surveillance Plans, AESI definitions, and escalation pathways.
- Review case series/targeted analyses and aggregate safety reports (e.g., DSUR, PBRER/PSUR); support SUSAR/expedited reporting oversight.
- Support regulatory interactions, briefing documents, and inspection readiness.
- Participate in DSMB/DMC interactions; support endpoint and safety adjudication.
- Provide drug safety leadership in matrix teams; support strategy implementation and process improvements.
- Ensure activities comply with GxP, ICH, and global regulations; support SOPs, deviations, CAPAs, and audits/inspections.
Education/Experience Requirements:
- MD or DO (or equivalent international medical degree).
- 8+ years in clinical development and/or pharmacovigilance, including medical monitoring.
- Interventional trial experience (Phase 1–3 preferred).
- Strong knowledge of global PV regulations and ICH.
- Experience with aggregate safety reporting (e.g., DSUR, PBRER/PSUR) and risk management planning (e.g., RMP).
Additional Skills/Experience:
- Early development/first-in-human/dose escalation (incl. DLT review); labeling/CCDS and post-marketing safety.
- Global filings and interactions with FDA/EMA/health authorities.
- Strong clinical judgment, communication, and ability to translate safety data into recommendations.
- Travel domestically/internationally up to 20–25%.
Benefits:
- Premium health, financial, work-life and well-being offerings; wellness and employee support programs; life insurance; disability; retirement with employer match; generous paid time off.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.