Adagene Incorporated

Lead medical oversight for early-phase immune-oncology trials, focusing on patient safety, data integrity, and the management of immune-related adverse events. Responsible for safety reporting, site training, and collaborating with investigators to optimize clinical protocols.

Lead the clinical development strategy and execution for immuno-oncology assets across Phase I-III trials. Serve as the primary Medical Monitor ensuring patient safety and managing regulatory interactions with the FDA and EMA.

The Study Physician provides medical expertise and oversight for the entire clinical trial lifecycle, focusing on medical monitoring and assessing drug-induced safety findings in light of patient safety. Key functions include supervising external contract organizations, ensuring project plans align with SOPs and regulations, and leading sponsor study processes like kick-off meetings and TMF setup.

This leadership role is accountable for global regulatory and quality strategies, providing guidance for compliance and overseeing submissions to regulatory authorities like the FDA and CFDA. The individual will lead cross-functional teams, represent the company in regulatory discussions, and contribute to clinical, R&D, and operations strategies.