Director, Clinical Monitoring Strategy and Oversight

Role: Lead strategic oversight of Moderna's global clinical monitoring model, focusing on risk-based, centralized, remote, and digital monitoring approaches to ensure patient safety, data integrity, and regulatory compliance. Responsibilities include defining and evolving monitoring strategies, integrating innovative analytics and automation, managing CRO and vendor oversight, and driving digital transformation initiatives. The leader collaborates with Clinical Operations, Risk & Compliance, Data Management, and Quality teams to align monitoring practices with regulatory expectations and industry best practices. Requirements: Bachelor's degree in Life Sciences or related field; 13+ years in clinical research, operations, or quality with expertise in monitoring strategies across multiple therapeutic areas and phases; deep knowledge of ICH GCP, risk-based monitoring, and analytics platforms; proven leadership and stakeholder management skills. Preferred: advanced degree, experience with digital health technologies, and global regulatory engagement. High-Value: focus on risk-based monitoring frameworks, CRO/vendor oversight, and digital innovation in clinical trials; global scope; up to 25% travel. Work setup: not explicitly stated but implies leadership within a matrix organization across global clinical programs.