Senior Director, Medical Monitor & Safety Physician

Role: Senior Director, Medical Monitor & Safety Physician, leading clinical safety oversight for Nephrology and/or Metabolic programs. Objectives include ensuring subject safety, conducting medical reviews, supporting benefit-risk assessments, and contributing to safety strategy execution in Phase 1–3 and post-marketing trials. Responsibilities encompass medical monitoring of clinical studies, safety data review, development of risk management plans, support for regulatory interactions, and cross-functional collaboration with Clinical Development, Pharmacovigilance, and Regulatory teams. Qualifications: MD or DO with 8+ years in clinical development/pharmacovigilance, experience supporting interventional trials (Phase 1–3 preferred), and strong knowledge of global PV regulations and ICH guidelines. Preferred skills include experience in early development, first-in-human studies, dose escalation, and global regulatory interactions. High-value details: focus on rare disease, nephrology/metabolism, GxP compliance, safety signal assessment, aggregate safety reporting, risk management, and safety strategy. Work setup: hybrid/remotely based in San Diego with up to 20–25% domestic/international travel; face-to-face work required.