Associate Director, Clinical Trial Patient Safety

Role: Oversee global clinical trial patient safety surveillance within the CTPS organization, ensuring high-quality, compliant, and timely adverse event data management. Responsibilities include managing safety data review processes across assigned studies, supporting training and talent development, and collaborating with therapeutic area medical monitors for safety oversight. The role involves applying knowledge of ICH, FDA, EMA regulations, and implementing continuous process improvements, SOPs, and regulatory updates. The position requires establishing effective communication with clinical, medical, regulatory, compliance, and pharmacovigilance teams, and managing a team of 5–10 safety professionals. Qualifications: Bachelor’s in Life Sciences, Pharmacy, Nursing, or biomedical disciplines; 10+ years in clinical research within pharma, with expertise in drug safety, clinical operations, or risk management. Experience managing cross-functional projects, understanding drug development stages, and working in multidisciplinary teams. Skills include leadership, communication, conflict management, and knowledge of global safety standards. High-Value: Focus on clinical safety in pharma development, regulatory compliance, and team leadership in a multi-therapeutic setting. Work setup: Not specified; likely office-based with potential for remote depending on location.