Associate Director/Director, Clinical Operations Compliance

Role: Associate Director/Director, Clinical Operations Compliance at Scholar Rock, focused on ensuring clinical trial adherence to GCP, ICH, FDA, EMA standards, and inspection readiness. Responsibilities: develop and review SOPs, oversee TMF standards, support outsourcing and vendor management, provide compliance oversight of clinical activities (trial management, monitoring, data, IMP, closeout), lead issue resolution, and contribute to regulatory submissions. Serve as subject matter expert on compliance requirements, facilitate training, and support inspection activities, including mock audits. Collaborate cross-functionally with Regulatory, Quality, Data Sciences, and Clinical Research teams. Requirements: Bachelor's in a scientific discipline; 8+ years in biotech/pharma/CRO, including 6+ years clinical operations and 3+ years supervisory experience. Proven success in complex drug development trials, inspection readiness, and regulatory compliance. Skills: strong leadership, organization, communication, and problem-solving; in-depth knowledge of GxP and global regulatory guidelines. Preferred: advanced degree. High-Value: experience with biologics or neuromuscular diseases, clinical trial oversight, inspection preparedness, and global regulatory standards. Work setup includes some flexibility for in-office days and international travel.