Senior Director, Medical Monitor & Safety Physician

Position Summary:
Senior Director, Medical Monitor & Safety Physician—clinical and safety leader responsible for medical monitoring and operational safety oversight of Nephrology and/or Metabolic clinical programs. Provides hands-on medical monitoring, supports benefit-risk evaluation, and executes safety strategy with cross-functional teams.

Responsibilities:
- 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 with safety medical guidance and risk mitigation training.
- Lead/support clinical event review (AEs, SAEs, AESIs): seriousness, expectedness, relatedness, and follow-up requirements.
- Provide medical input into informed consent forms, protocol/IB safety sections, and study-level safety management plans.
- Contribute to benefit-risk assessments; participate in safety review meetings; provide risk mitigation and communication input.
- Support RMPs, safety surveillance plans, AESI definitions, and escalation pathways.
- Review DSUR/PBRER/PSUR and other aggregate safety information; support SUSAR/expedited reporting oversight.
- Contribute to regulatory interactions, briefing documents, and inspection readiness.
- Participate in DSMB/DMC interactions and safety adjudication processes.
- Provide drug safety leadership in matrix teams; support strategy implementation and process improvements.
- Ensure compliance with GxP, ICH, and global regulations; support SOPs, deviation investigations, CAPAs, and audits/inspections.

Qualifications:
- MD or DO (or equivalent international medical degree).
- 8 years’ experience in clinical development and/or pharmacovigilance, including medical monitoring responsibilities.
- Experience with interventional clinical trials (Phase 1–3 preferred).
- Strong understanding of global PV regulations and ICH guidelines.
- Demonstrated experience with aggregate safety reporting (e.g., DSUR, PBRER/PSUR) and risk management planning (e.g., RMP).

Additional Skills/Experience (preferred/required as stated):
- Early development/first-in-human/dose escalation (including DLT review); labeling/CCDS; post-marketing safety.
- Experience with global filings and FDA/EMA and other health authorities.
- Strong clinical judgment, ability to translate safety data into actionable recommendations, clear communication, organizational skills, matrix influence, compliance/inspection readiness.
- Travel domestically/internationally up to 20–25%; onsite presence in San Diego required (not 100% remote).

Benefits:
- Premium health, financial, work-life/well-being offerings; wellness and employee support programs; life insurance; disability; retirement with employer match; generous paid time off.
- Target base pay range: $233,000.00–$315,000.00.

Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.