Fiona Zeng

Line manage a group of Global Study Leaders, Global Study Associate Managers and Global Study Associates.

Lead and manage a cross Functional team to operationally deliver defined clinical studies or clinical project activities to time, cost and appropriate quality.

Responsibility of CTL: 1. Responsible for the planning and implementation of all operational aspects of assigned phase I or phase IIa studies: registration studies (PK studies, Bioequivalence studies) in China and First-in-Human studies, Proof-of-Concept (PoC) studies, profiling studies globally. 2. Accountable for the writing of clinical protocols and related documents in collaboration with the Clinical Trial Team (CTT) 3. In collaboration with CTT, lead the ongoing review of the clinical trial medical/scientific data (as needed), analysis and interpretation including the development of First Interpretable Results (FIRs) and Clinical Study Reports (CSRs).

Monitored 5 clinical trials, accumulated significant experience in both oncology and RA studies. Assigned as Country Study Manager in 2008, led 4- 5 team members, conducted 1 local phase III Oncology study and 1 global phase III RA study. Accumulated experience in site selection, budget control, quality management as well as cross-functional communication.