Global Program Director Early Phase

The Global Program Director (GPD) is a business-critical role within Development Operations whose main accountability is the operational planning and delivery of high priority and complex clinical studies within a program, or across programs that are deemed most critical to the business. The GPD is responsible for leading across functional study team (core and extended) and for providing the team with direction and guidance to enable successful study delivery. The GPD may provide input to early study planning activities based on operational expertise. The GPD is accountable to the GPT for the delivery of a study, or studies, according to the agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within the study team. The GPD will also interface with other internal stakeholders cross-functionally, and / or external partners, to identify, manage and resolve issues affecting study delivery.

The GPD is also responsible for providing expert input, guidance, direction, mentoring, and support to GSADs on all study related operational activities. The GPD will also provide advice and support to GSAD related to study team leadership, senior stakeholder management, conflict management, etc. GPDs will also lead other non-drug programs and improvement projects as required.

You will be responsible for :

• The GPD may act as a lead for CRO partnerships in the Phase 1 outsourced studies.
• Accountable for the implementation and execution of clinical studies under the Phase 1 portfolio.
• Member of the Core Team, in representation of Clinical Operations. Leads and provides oversight to Global Study Managers (GSMs) and Global Study Associate Directors (GSAD) assigned to related Program.
• Directly accountable and responsible for the planning, implementation and execution of the outsourced studies under the Phase 1 portfolio.
• Acts as a core member of the Global Project Team, representing Clinical Operations.
• Leads and provides oversight to GSMs and GSADs assigned to related Programs, ensuring consistency across all studies within the Program.
• Contributes strategic and operational assessment (i.e., risk management / feasibility assessment) to the development of the Global program.
• Accountable to GPT Leader for planning, tracking and forecasting the Global Clinical Operations budget, resources (allocation) and timelines for the program against the agreed goals.
• Develops and maintains budgets for study(s) that include short and long-range clinical forecasting and monthly accruals based on clinical activity to support Clinical Development financial goals.
• Collaborates with the appropriate Functions in defining the sourcing strategy for the clinical studies and provides oversight and management of CROs in outsourced studies.
• Establishes the operational standards for the program (e.g., monitoring plans, risk mitigation strategy, and oversight of operational vendors).
• Reviews all key deliverables for consistency across the program. Ensures compliance with the International Conference on Harmonization - Good Clinical Practice (ICH-GCP) and EU Clinical Trial Directive throughout the entire clinical development plan. Develops in-depth knowledge of the clinical data and ensures appropriate transfer of that knowledge to cross functional study teams to achieve operational excellence.
• Provides input to Program & Portfolio Management, in case of project prioritization exercises within the portfolio.
• Leads or contributes to the Development Operations functional excellence efforts and initiatives, which affect cross-functional processes, as requested.
• Support other study and functional activities, as assigned.

You will need to have :

We would prefer for you to have :

Date Posted : 10-Feb-2025

Closing Date : 24-Feb-2025

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