Senior Director, Medical Monitor & Safety Physician

About the role

This senior clinical safety leadership position is responsible for patient safety and benefit‑risk evaluation across global nephrology and metabolic disease programs. The role combines hands‑on medical monitoring with strategic pharmacovigilance oversight from early development through post‑marketing.

Key responsibilities

• Serve as Medical Monitor for Phase 1‑3 and post‑marketing trials, providing real‑time oversight and ensuring protocol compliance.
• Review adverse events, serious adverse events, dosing decisions, eligibility questions and safety signals, determining relatedness, expectedness and seriousness.
• Develop safety strategies, including Risk Management Plans, safety surveillance frameworks, AESI definitions and escalation pathways.
• Provide clinical input to study protocols, informed consent, investigator brochures and safety management plans.
• Lead aggregate safety analyses and reporting (DSURs, PSUR/PBRERs, case series, targeted assessments).
• Support regulatory interactions, inspection readiness and safety‑related submissions.
• Participate in DSMB/DMC processes, adjudication committees, investigator meetings and cross‑functional governance forums.
• Drive continuous improvement of safety systems, SOPs, CAPAs and quality processes in line with GxP and ICH guidelines.

Required profile

• MD or DO (or equivalent international medical qualification).
• 8+ years of experience in clinical development and/or pharmacovigilance, with substantial medical monitoring experience in interventional trials.

Required skills

• Medical monitoring
• Pharmacovigilance
• Risk Management Plan development
• GxP compliance
• ICH guideline knowledge