The Head of Feasibility (HF) is responsible for developing winning country, site, patient, and data strategies to ensure the platform’s operational success with adherence to study timelines. In this role you will provide expert guidance on country and site selection strategies, regulatory considerations and start-up timelines, as well as patient access considerations, using operational experience, clinical trial knowledge, real-world data (RWD) and predictive analytics, thus ensuring efficient, accelerated and successful operational delivery. You will oversee the design of each therapeutically customized site identification and patient strategy with the start-up team, collaborates with Project Management Leads, Clinical Trial Management, as well as drug development experts, to ensure that the overarching strategy is operationally realized within the agreed upon timelines and budgets. You will apply an objective and data-driven approach to significantly influence the functional strategy, designed to give the competitive edge. The Head of Feasibility will exhibit an in-depth understanding of emerging use of real-world evidence (RWE) and predictive analytics; demonstrate an ability to discover, evaluate and/or recommend innovative data-driven approaches; and a willingness to explore ground-breaking technologies in RWE, AI or other spaces, ensuring is the global leader in feasibility. Main Responsibilities include Vaccine Strategy and Coordination, Leadership/Management of a Study Startup team, Communication/Interfaces, Coordination of Study Start-up Activities, Planning/Resources/Budget/Risks, Process Improvement, Department Leadership, Expertise and Consultation, Process Implementation, Partner Management, Committee Participation, and Team Development. The role requires managing a global and multicultural team, ensuring operational delivery on time and within budget, and driving excellence in applied life sciences, real-world evidence, and bioinformatics services in drug development. Education and Experience required include a Bachelor's degree in a relevant field, 12+ years experience in vaccinology or clinical research, people management experience preferred, formal training in GCP methods, proven track record in delivering high quality GCP-compliant Clinical Trials, knowledge of US regulatory requirements, and skills in project and budget management.
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