Clinical Operations and Study Leader

Summary of purpose/major responsibilities The Clinical Operations and Study Leader (COSL) combines Clinical project and study oversight roles and responsibilities for Vaccines projects activities. For projects activities (project and study oversight, CTD submission, PAI…), the COSL will cover both COL and GSM activities. The COSL is a key leadership role within the assigned project. The COSL directs and manages clinical operational activities to support the Global Clinical Development Strategy Expert (GCDSE) and the clinical team in project and study activities. She/he is accountable for ensuring study activities and clinical deliverables are on time and within budget, collaborating actively with all functions in the project and clinical teams as well as functions in Clinical. The COSL is the trusted and reliable chief liaison between the various platforms within GCD and acts as well as an interface with other enabling functions such as JPH, GPM, GRA, PSPV, CMQO, GMA, EPI, BSM, and GI, especially in the context of issues resolution. Therefore, it involves working with multiple levels of personnel from many platforms, in multiple regions, as well as with external stakeholders (e.g., advisory boards, CROs). The COSL is accountable for ensuring the deliverables of the clinical project and/or studies activities via effective project management and leadership skills in a manner that will optimize integrate and utilize the team’s resources and competencies. The COSL will support the clinical project and studies strategy by providing expertise to develop the best operational strategy for the successful conduct of the project and delivery of the studies. It requires an excellent understanding of franchise/project strategic objectives, clinical operational activities, and clinical studies constraints including Japan regulations, as well as superior interpersonal skills. The COSL ensures an effective cross functional communication and consolidates strategic communication at project level as well as study level. The COSL supports innovation and entrepreneurial mindset such as clinical trial designs, digital methodologies, and tools as well as organization within the extended clinical and clinical teams. The COSL is a key role in risk management initiatives and coordinates crisis management within the project/studies. The chief accountability is to ensure reliable performance and productivity of Clinical project/studies by leading and coordinating project and studies activities and services. Accountable for both project and study deliverables within GCD, including the timelines, quality and budget . Key accountabilities Project strategy and coordination Provides operational input into the clinical project strategy by providing expertise to develop the best operational and scientific strategy for the successful conduct of the project. Knowledgeable about and understands overall project and franchise strategy. In collaboration with the GCDSE, provides support for clinical project governance. Ensures the Clinical Development Plans are communicated throughout the Extended Clinical Team and the R&D Project Team and to ensure alignment with R&D global project strategy. Accountable for Clinical project performance to ensure it meets expectation with respect to timelines, quality and budget. Contributes to ensure harmonization of activities (operational strategy) in between studies within a program and transversally and across clinical projects/programs, as well as alignment between local and global. Manages the planning and feasibility of execution of the clinical study/project/program performed as part of the Clinical Development Plan. Develops the planning and drives execution of the clinical sections of the required regulatory submissions and communicates status updates (i.e. CTD, eBLA, PAI, and others as appropriate). Monitors projects’ progress and performance against strategic objectives and key performance indicators. Ensures proactive, t