Tokyo,12.0M ～ 15.0M
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.
-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, timely reporting on progress of program management components of clinical trials, openly escalate issues that require input from and discussion with members of Clinical Management.
Communication/Interfaces
-Consolidates strategic communication at project/program level and maintains cross functional communication.
-Acts as an interface between the Extended Clinical and Clinical Teams and other enabling functions such as GRA, PSPV, CMQO, GMA, EPI, PPFP and GI, especially in the context of issues resolution.
-Ensures oversight of the CRO involved in the monitoring of the study.
-Ensures effective cross-regional communication to allow clinical teams to function efficiently to achieve global plans. Ensures top down/bottom-up communication.
-In collaboration with the GCDSE arranges scientific advisory boards, adjudication committees and experts committees, set up, follow-up, communication and manages partnership/alliance with experts.
Leadership
-Is a member of R&D project (including local), extended clinical, and clinical teams member for assigned projects.
-Actively engages in decision-making process with other stakeholders in GCD, providing input as needed to Head, GCD and Global Heads of clinical platforms.
-Provides guidance on best practices and lessons learned for operational execution of clinical trials. Facilitates operational issue resolution. Leads risk management initiatives for the clinical project to minimize negative impacts to team deliverables.
-Coordinates crisis management within clinical project/program and interface with Clinical platforms and beyond to define and implement action plan.
-In collaboration with team member’s manager, mentors team members to develop enhanced leadership skills such as consensus-building and conflict resolution. Encourages and supports team member empowerment. Is a trusted liaison for Clinical and other stakeholders across platforms and functions.
Budget
-Ensures appropriate project level capacity/resource planning and management in conjunction with other functions within GCD.
-Consolidates and review budget and resources allocation for clinical project/study activities through transversal reviews and interact with BO, FP and R&D Finance to ensure the Clinical budget and planning is accurate.
-Is accountable for tracking and monitoring the project/program budget with support of BO.
Learning/continuous improvement
-Supports innovation and entrepreneurial mindset such as clinical trial designs, digital methodologies and tools as well as organization within the clinical project/program.
-Establishes culture of continuous learning and improvement in the clinical project. Identifies process issues requiring resolution at the project level and proposes solutions.
-Identify opportunities for improving organizational processes to continue to drive organizational excellence
-Ensures that ‘lessons learned’ approach is built into the review and adoption of new approaches and methods.
-Stays abreast of advances in his/her area of expertise.
