Location: Barcelona, SpainJob reference: R-219396Date posted: 02/10/2025This is what you will do: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 teamleadership, 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 outsourcedmodels.- Accountable for the implementation and execution of clinical studies underthe Phase 1 portfolio.- Member of the Core Team, in representation of Clinical Operations. Leadsand provides oversight to Global Study Managers (GSMs) and Global StudyAssociate Directors (GSAD) assigned to related Program.- Directly accountable and responsible for the planning, implementation andexecution of the outsourced studies under the Phase 1 portfolio.- Acts as a core member of the Integral Project Team, representing ClinicalOperations.- Leads and provides oversight to GSMs and GSADs assigned to relatedPrograms, ensuring consistency across all studies within the Program.- Contributes strategic and operational assessment (i.E., riskmanagement/feasibility assessment) to the development of the GlobalDevelopment Plan (GDP).- Accountable to GPT Leader for planning, tracking and forecasting the GlobalClinical Operations budget, resources (allocation) and timelines for theprogram against the agreed goals.- Develops and maintains budgets for study(s) that include short and longrange clinical forecasting and monthly accruals based on clinical activity to support Clinical Development financial goals.- Collaborates with the appropriate Functions in defining the sourcingstrategy for the clinical studies and provides oversight and management ofCROs in outsourced studies.- Establishes the operational standards for the program (e.G., monitoringplans, risk mitigation strategy, and oversight of operational vendors (e.G.,monitoring, labs, imaging, etc.).- Reviews all key deliverables for consistency across the program. Ensures compliance with theInternational Conference on Harmonization - Good Clinical Practice (ICHGCP) and EU Clinical Trial Directive throughout the entire clinicaldevelopment plan. Develops in-depth knowledge of the clinical data andensures appropriate transfer of that knowledge to cross functional studyteams to achieve operational excellence.- Provides input to Program & Portfolio Management, in case of projectprioritization exercises within the portfolio.- Leads or contributes to the Development Operations functional excellenceefforts and initiatives, which affect cross- functional processes, as requested.- Support other study and functional activities, as assigned.You will need to have:- Experience of clinical research experience, 8 of which in leading rolesaccountable for the planning, execution and reporting of global clinical trialsof diverse development phases (I - IV).- Bachelor’s degree or equivalent in one of the disciplines related to clinicalpractice/health care, life sciences, or drug development.- Ability to lead cross-functional teams and to represent clinical operations inCore - Product Development Teams. Solid understanding of integrateddevelopment process for pharmaceuticals products.- Leadership, project management, resource management are required.- The duties of this role are generally conducted in an office environment. Asis typical of an office-based role, employees must be able, with or without anaccommodation to: use a computer; engage in communications via phone,video, and electronic messaging; engage in problem solving and non-linearthought, analysis, and dialogue; collaborate with others; maintain generalavailability during standard business hours.We would prefer for you to have:- Advanced degree (