Humacyte - Durham, NC
posted about 2 months ago
The Executive Director, Head of Clinical Monitoring and Safety at Humacyte Inc is a pivotal leadership role responsible for overseeing the clinical and medical monitoring of all clinical trials, as well as ensuring safety and pharmacovigilance post-launch. This position requires a deep understanding of clinical trial data and the ability to interpret this data effectively. The Executive Director will provide strategic direction and medical oversight for clinical trials, contributing as a key member of the leadership team and collaborating with various functions such as regulatory, commercial, medical affairs, quality, manufacturing, and finance on strategic initiatives. In this role, the Executive Director will participate in the review and development of critical documents including protocols, Investigator Brochures (IB), Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), and Periodic Safety Update Reports (PSURs). They will lead the design and conduct of Post-Marketing Pharmacovigilance Studies and work closely with the clinical operations team and Contract Research Organizations (CROs) to provide medical monitoring expertise, ensuring the delivery of high-quality data from clinical trials. The Executive Director will also be responsible for developing, monitoring, and managing Key Performance Indicators (KPIs) to track the progress of ongoing clinical studies, ensuring compliance with SOPs, GCPs, ICH guidelines, and all applicable regulations. This role includes personnel management for the safety team, encompassing recruitment, retention, performance management, and career development. The Executive Director will represent Humacyte at selected conferences and meetings, collaborating with Regulatory & Quality teams to ensure compliance with clinical trial conduct and safety reporting requirements. Additionally, they will assist the New Product Development team on future indications, advising on pre-clinical studies as necessary.