Vice President, Clinical Compliance and Systems

Role: Strategic Vice President, Clinical Compliance & Systems within Clinical Operations, leading the development of compliance, inspection readiness, TMF governance, and clinical systems infrastructure. Responsibilities: establish strategic vision, build and mentor high-performing teams, oversee clinical compliance activities in line with global regulations (ICH-GCP, ICH E6(R3)), and modernize clinical processes and technology platforms (eTMF, CTMS). Collaborate across functions including Quality, IT, and Development Sciences to ensure scalable, compliant, and innovative clinical trial operations. Develop and execute roadmaps for clinical systems, oversee system selection, integration, validation, and lifecycle management, and evaluate emerging digital technologies. Drive operational excellence through metrics, dashboards, and continuous improvement initiatives. Qualifications: Bachelor's degree in science, healthcare, or related field; 15+ years in Clinical Ops, Quality, or Systems within pharma/biotech; proven leadership in building and developing teams; deep knowledge of global clinical trial regulations and systems; strategic thinker with strong influencing skills; experience operating in fast-paced, innovative environments. High-Value: focus on clinical development, compliance, and systems infrastructure for a growing biotech portfolio, including post-bariatric hypoglycemia, Wolfram syndrome, and ALS, with remote work flexibility and periodic travel to Cambridge, MA.