Senior Director, Medical Monitor & Safety Physician

Role: Senior Director, Medical Monitor & Safety Physician, leading clinical safety oversight for Nephrology and/or Metabolic programs in Phase 1–3 and post-marketing. Objectives: ensure subject safety, support benefit-risk assessments, and contribute to safety strategy execution within a global, rare disease-focused environment. Responsibilities: serve as Medical Monitor, conduct medical reviews, support risk management and pharmacovigilance activities, review safety data, participate in safety committees, and ensure compliance with GxP and global regulations. Collaborate across clinical development, PV, regulatory, and operations teams, and support regulatory interactions and inspection readiness. Qualifications: MD or DO with 8+ years in clinical development/pharmacovigilance, with experience in early clinical trials and global PV regulations. Skills include medical monitoring, safety reporting (DSUR, PBRER/PSUR), risk management, and strong communication. High-value specifics: rare disease focus, global trial oversight, regulatory interaction experience, and travel up to 20–25%. Work setup: remote with face-to-face requirements in San Diego.