Senior Director, Medical Monitor & Safety Physician

About the role

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.

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, non-clinical, 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.

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

• Experience in early development, first-in-human studies, and dose escalation (including DLT review).
• Experience supporting labeling, CCDS development, and post-marketing safety activities.
• Experience with global filings and interactions with FDA/EMA and other health authorities.
• Strong clinical judgment and patient safety mindset.
• Ability to translate complex safety data into clear, actionable recommendations.
• Effective written and verbal communication, including medical storytelling.
• High standards for compliance, quality, and inspection readiness.
• Ability to influence in a matrix environment and collaborate across functions.
• Strong organizational skills with the ability to manage multiple priorities.
• Embody Travere’s core values: Courage, Community Spirit, Patient Focus, Teamwork.
• Strong interpersonal and communication skills.
• Able to work effectively in a multidisciplinary, inclusive environment.
• Able to adapt to changing project plans and evolving priorities.
• Able to travel domestically and internationally (up to 20–25%).