At the project level, the Clinical Lead, ECET Oncology China will be a member of the asset Global Project Team and the Translational Medicine Subteam. In these roles, duties include:
Design safe, rapid and informative First-In-Human studies for oncology assets potentially iincluding natural history, experimental model validation, mechanistic and signal seeking, streamlined Proof-of-Mechanism as well as Proof-of-Concept studies providing robust data for early Go/No Go decisions and other pharmacokinetic studies.
Participate in designing the early development plan and overall ECET plan for the different steps of clinical development, integrating into to the overall development strategy in collaboration with the responsible Therapeutic Area in research and development.
Decision Making Authority: Make front-line decisions on protocol design, execution, dose escalation and safety, information for Regulatory authorities.
Supervise the successful execution of the clinical study
Oversight of medical monitoring.
Review, interpret results, and author ECET-related clinical documentation, including informed consent forms, clinical protocols, study reports; some abstracts and/or manuscripts; clinical pharmacology or ECET components of investigator brochures, regulatory documents.
Interact effectively with managers from various disciplines; serve as expert and internal consultant on assigned area and liaises with partners on projects.
Participate in the dose selection for First-In-Human studies, drive Go/No Go decisions when needed.
Ensure an adequate follow-up of studies and project timelines.
Ensure Clinical Trial standards are maintained at the site and in cooperation with the other clinical functions. Requires excellent communication skills and the implementation of an appropriate process for communication.
Ensure high quality documents, requiring strong writing and communication skills.
Manage aggressive timelines effectively through cross-functional planning.
Maintain effective collaborations with local KOLs/PIs
Present data at appropriate meetings (inside or outside Sanofi)
At the clinical study level, the individual will also serve as Study Medical Manager (SMM) for selected clinical studies. SMM principal duties and responsibilities include:
Study preparation:
Design and conduct early clinical development studies FIH to phase 2a within planned timelines (supported by an operational team).
Review and approve study documentation (monitoring plan, statistical analysis plan, contracts, regulatory documents, etc.).
Coordinate clinical team to set-up and follow the study.
Ensure proper documentation is provided to the Ethics Committees and Health Authorities.
Study conduct:
Ensure that the study is scientifically sound and correctly conducted.
Coordinate oversight of CROs or outsourced activities
Coordinate cross-functional communication and cooperation
Prepare and review the interim investigator reports.
Lead the Dose Escalation Meeting and document decision making (for First-in-Human studies).
Review the Adverse Event reports.
Oversight of safety monitoring
Study validation and reporting:
Participate in the data review and validation meetings before database lock.
Review and interpret the results.
Prepare and distribute the Key Results Memo and prepare/review the Clinical Study Report.