Adagene - San Diego, CA
posted 29 days ago
The Director, Study Physician at Adagene Inc. plays a pivotal role in the clinical operations team, providing essential medical expertise and oversight throughout the entire clinical trial process. This position encompasses responsibilities from the initial design of the study to its final close-out, ensuring that all medical monitoring and safety activities are conducted with the utmost diligence. The medical monitor is integral to the cross-functional clinical team, contributing actively to the development of each assigned study in early development phases. This role is crucial for assessing and understanding drug-induced safety findings, always with a focus on patient safety. In this capacity, the Director will closely supervise external contract organizations responsible for various critical activities, including site interaction, monitoring, data management, and pharmacovigilance. The individual will ensure that effective project plans are operational for each trial, working proactively with the Clinical Trial Team (CTT) to prioritize tasks in alignment with project plans, company standard operating procedures (SOPs), and regulatory requirements such as ICH/GCP guidelines. The Director will maintain oversight of study conduct at various centers, ensuring adherence to protocols and Good Clinical Practices (GCP) throughout the study lifecycle. The role also involves leading the sponsor study process, which includes conducting the Trial Kick-off meeting, setting up the trial master file (TMF), and finalizing site and vendor agreements. The Director will review and approve site visit reports, ensuring timely tracking and resolution of any site issues. Additionally, the position requires proactive management of project-level operational aspects, including trial timelines, budgets, resources, and vendor relationships. Establishing and maintaining strong working relationships with clinical study site personnel is essential to ensure quality data provision and adherence to study timelines. The Director will oversee Clinical Site Managers and Clinical Research Associates (CRAs) in trial conduct, monitor vendor deliverables, and address any quality issues that arise. This role also includes collaboration with the Director of Quality and Compliance to review vendor responses to audits and ensure compliance with company SOPs and regulatory requirements. The Director is accountable for developing and managing the Clinical Operations budget, reviewing draft protocols, and ensuring that all project-level documentation is properly filed in the TMF. Overall, this position is critical for ensuring the successful execution of clinical trials and the integrity of clinical data.