Unclassified - Durham, NC
posted about 2 months ago
Humacyte Inc (Nasdaq: HUMA) is at the forefront of developing a groundbreaking biotechnology platform aimed at delivering universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems. The Executive Director, Head of Clinical Monitoring and Safety, plays a pivotal role in leading and 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 it effectively, as well as experience in medical monitoring and collaboration with Contract Research Organizations (CROs). The Executive Director will be a key member of the leadership team, interfacing with various functions such as regulatory, commercial, medical affairs, quality, manufacturing, and finance to drive strategic initiatives. In this role, the Executive Director will provide strategic direction and medical oversight for clinical trials, participate in the review and development of essential documents such as protocols, Investigator Brochures, Clinical Study Reports, and Safety Update Reports. They will lead the design and conduct of post-marketing pharmacovigilance studies, working closely with the clinical operations team and CROs to ensure high-quality data delivery from clinical trials. The Executive Director will also be responsible for developing and managing Key Performance Indicators (KPIs) to track the progress of ongoing clinical studies and ensure compliance with regulatory requirements. The position requires excellent communication and interpersonal skills, as the Executive Director will represent Humacyte at conferences and meetings, influence key stakeholders, and manage a team of safety professionals. The ideal candidate will possess a positive attitude, strong organizational skills, and the ability to thrive in a fast-paced environment with fluctuating priorities. This role is critical to ensuring that clinical studies are conducted in accordance with established guidelines and regulations, ultimately contributing to the advancement of Humacyte's innovative therapies.