By clicking the Apply button I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda s and I further attest that all information I submit in my employment application is true to the best of my knowledge OBJECTIVES PURPOSE Lead study operational strategy and planning and oversee execution of clinical studies for the assigned clinical program s supporting clinical strategy defined in Clinical Development Plan CDP In close collaboration with Clinical Operations Program Lead COPL and Clinical Study Manager CSM Responsible for oversight of the execution of studies in the assigned clinical program s in compliance with quality standards including ICH GCP local regulations and Takeda SOPs on schedule and on budget Oversight of strategic CRO partners and or other vendors to meet Takeda s obligations described in ICH-GCP and Takeda s business objectives Represent Clinical Operations to contribute to CDP by providing regional operational expertise and strategic inputs including study feasibility budget and timeline for assigned clinical programs ACCOUNTABILITIES Accountable for developing regional operational strategy for assigned clinical studies Contribute to the translation of CDP into an optimal operational strategy and plan Lead assessment of various scenarios operational for optimal execution of CDP Collaborate with key investigators to reflect feasible and realistic operational inputs to CDP and ensure timeline and quality of studies meet the needs of CDP Provide subject matter expertise and operational input into protocol synopsis and protocol obtaining opinions in terms of study execution from key investigators as appropriate Challenge study team to ensure that operational feasibility inclusive of patient and site burden and that timelines meet the needs of CDP Validate budget and ensure impacts are adequately addressed Participate in site selection process