Role description: • A global role within Global Development Operations (GDO) based at either US or UK GDO management locations • Reports (at a minimum) to: CPO TA Head. Responsible for: • Global clinical program operational strategy, planning, risk assessment and mitigation, and overall execution • High-quality execution of clinical trials on time and within budget • Leadership of the Global Clinical Studies Team (GCST) for the allocated program(s) • Providing clinical operations leadership and expertise on the Evidence Generation Team and in development of the Evidence Generation Plan (EGP) and PT as required • Providing clinical operations leadership and expertise in EGP execution through the feasibility and study design process • Development and oversight of clinical program budgets in collaboration with TA and Finance • Managing program-level operational issues and oversight of study team issue escalation • Maintaining global business relationships cross-functionally and communicating global status of clinical trial programs to senior management • Representing CPO on process improvement initiatives • Support CPO resource planning for assigned program(s) in collaboration with Program Resource Management (PRM) • Line management of CPO CPM-SMs / ADs Purpose / Accountabilities • Global single point of accountability for operational strategy, planning, risk assessment and mitigation, and overall execution of clinical trial programs • Support continuous improvement initiatives in CPO and throughout Global Development Operations (GDO) Key Activities • Oversee the operational design, planning and execution of all studies for the program • Oversee the development of timelines and budgets for studies within the program • Oversee people management, career development, training and succession planning of CPO Senior Managers and Associate Directors • Oversee structure and engagement of program CPO team • Input into product Clinical Development Planning (CDP) and evidence generation plans • Initiate and support conduct of Country Operational Landscape Assessments and study feasibility with Development Feasibility Senior Managers • Contribute operational expertise throughout study design coordinating cross functional input on a continuous basis • Provide advice on development of Key Design Elements (KDE) prior to Governance Body review • Provide visibility to study cost drivers and assumptions as refined throughout KDE and protocol development • Lead cross-functional team to create and periodically review/revise program & study Clinical Trial-Risk Assessment Categorization Tool (CT-RACT) • Evaluate if “Patient Voice” techniques should be incorporated on program and design, implement and measure the success of subject Recruitment and Retention Strategies • Accountable for study global enrolment plans, revised enrolment plans and accurate global recruitment forecasting • Support the resolution of cross-functional program issues escalated from the study teams and GCST and inform / escalate to TA Head and other stakeholders as appropriate • Leads the GCST to ensure operational consistency and standards across all clinical studies within the program • Communicate effectively with key stakeholders the program strategy and deliverables • Contribute to functional goal setting • Facilitate sharing of best practices, product knowledge and identify areas for process improvement within CPO • Review vendor evaluation to include identification of outsourcing requirements for study / program and oversee management of vendors. • Supports and oversees internal audit and inspection activities and contributes to CAPAs globally for the program • Lead planning for regulatory agency inspection readiness activities (e.g. TMF review) and ensure execution of plans • Represent the function by contributing and / or leading initiatives for the continuous improvement of clinical trial planning and execution. Contribute to development and maintenance of policies, SOPs and associated documents • Oversee the development of study diversity plans and ensure program actively engaging in DI&B strategies. Qualifications Basic Qualifications • Doctorate degree & 4 years of directly related experience or equivalent OR • Master’s degree & 8 years of directly related experience or equivalent OR • Bachelor’s degree & 10 years of directly related experience or equivalent AND • 4 years of direct managerial and/or leadership experience or equivalent Preferred Qualifications • PhD, PharmD, MSc., B.Sc., R.N • 11 years’ work experience in life sciences or medically related field, including 8 years of biopharmaceutical clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company • Previous management experience of direct reports, including management level staff • Experience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc.) Knowledge • Knowledge of global regulatory requirements and guidelines for conducting clinical research and safety monitoring / reporting • Project and Program management including oversight of study deliverables, budgets and timelines • Time, cost and quality metrics • Relevant operational expertise • Understanding of resource management and organizational capacity management • Experience in developing goals and training plans to maximize talent and career development of staff • Experience of managing projects in a matrix organization • Ability to network and build relationships to maximize organizational and functional capabilities • Experience in leading organizations through change • Relevant therapeutic knowledge. Key Competencies • Departmental Leadership • People Management • Project Management • Matrix team leadership • Strategic Operational Planning • Relationship Management and negotiation and influencing skills • Risk assessment/ risk mitigation • Innovation • Decision Making and Problem Solving • Conflict Management • Oral and Written Communication • Scientific / Technical Excellence • Financial Management • Flexibility / Adaptability.