Adagene Incorporated
Remote Jobs
2 Jobs
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.