Global Clinical Trials Leadership Role
A global leadership position within Global Development Operations (GDO) based at either US or UK GDO management locations, reporting to the Chief Product Officer (CPO) - TA Head.
This role is responsible for:
* Developing and implementing global clinical program operational strategies, plans, risk assessments, and mitigation.
* Ensuring high-quality execution of clinical trials on time and within budget.
* Leading the Global Clinical Studies Team (GCST) for allocated programs, providing clinical operations leadership and expertise.
* Contributing to the development of the Evidence Generation Plan (EGP) and Project Timeline (PT).
* Managing program-level operational issues and overseeing study team issue escalation.
Main Responsibilities:
* Overseeing the operational design, planning, and execution of all studies for the program.
* Developing timelines and budgets for studies within the program.
* Maintaining global business relationships cross-functionally and communicating global status of clinical trial programs to senior management.
* Supporting continuous improvement initiatives in CPO and throughout Global Development Operations (GDO).
Key Activities:
1. Initiating and supporting Country Operational Landscape Assessments and study feasibility with Development Feasibility Senior Managers.
2. Providing operational expertise throughout study design, coordinating cross-functional input on a continuous basis.
3. Contributing to the development of Key Design Elements (KDE) prior to Governance Body review.
4. Evaluating if