The Global Clinical Operations Program Director (GPD) is a core global role within the Clinical Operations function of Late Stage R&D (Biopharmaceuticals and Oncology). The span of responsibilities is broad and may support one or several products depending on scope and complexity. The products supported will be in Phase 3 development or on the market, but the program may include studies in all phases of drug development.
On behalf of the Senior Global Clinical Operations Program Director (Sr GPD), the GPD provides strategic operational leadership and oversight of a suite of globalclinical studies within a program covering all clinical program deliverables, covering all clinicaloperations deliverables to scope, quality, budget, time, resource, and risk, ensuring new innovative design and delivery models are used appropriately.
The role involves integrating strategy, design, feasibility and operational planning to produce business-focused clinical drug development programs that align with priorities and strategy. The GPD will develop the core clinical operations components for governance interactions with the oversight of the Sr GPD. The GPD may also act as the lead for crossfunctional teams in delivery of clinical program team (CPT) activities assigned.
The GPD may provide project leadership for cross-functional clinical submission teams in support ofregulatory marketing applications and post-registration product maintenance deliverables.
Additionally, the GPD may lead or contribute to improvement and change projects within clinicaloperations and/or other business areas.
<<Back to job information