Associate Director, Clinical Program Management

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 with a focus on providing country insights and therapeutic expertise to ensure alignment between study execution plan and program strategy Responsible for clinical study budget planning and management and accountable for external spending related to clinical study execution Works closely with relevant stakeholders strategic CRO partners other vendors CSM COPL and Program Management Outsourcing and Finance to ensure the accuracy of budget spending on a regular basis Oversee strategic CRO partners and other vendors to ensure the overall operational execution and delivery of the assigned clinical studies in compliance with quality standards including ICH GCP local regulations and Takeda SOPs on schedule and on budget Oversight includes but is not limited to Review and approval of key risk-based monitoring documents plans periodic review of outputs decisions and actions related to risk-based monitoring Documented review and monitoring of issues risks and decisions at the study level Support the identification of trends across sites and or the study Review and provide clinical operations expertise into clinical documents related to the drug development process Creation and maintenance of clinical trial materials such as Investigator Brochures study synopsis protocols clinical study reports etc Preparation of key regulatory meetings as appropriate Collaborate with cross-functional counterparts and strategic CRO partners other vendors to ensure inspection readiness and lead Clinical Operations aspects of inspection readiness activities and act as subject matter expert during regulatory inspections Actively seek new ways of working more efficiently to meet the needs of clinical development such as cost-reduction time-savings efficiency and quality Participate in Business Development in-licensing alliances evaluations by providing operational due diligence Responsible for talent development including training and mentoring less experienced staff Seek an efficient way to maximize operational excellence in the cross-regional collaboration e g Japan Asia with innovative ideas CORE ELEMENTS RELATED TO THIS ROLE Program Provide operational expertise and strategic inputs to the development of CDP and lead assessment of various operational scenarios for optimal execution of CDP Recognized as a clinical operations expert by other functions and stakeholders across R D Organization Actively seek new ways of executing studies more efficiently to meet the needs of clinical development and encourage the function Capability development In addition to the self-development think about supporting the development of Clinical Operations staff by sharing knowledge and experience with them DIMENSIONS AND ASPECTS Technical Functional Line Expertise Have sufficient knowledge of regulatory and compliance requirements and guidance for clinical development assigned Therapeutic Areas TAs project governances and working models and accurately assess the impact of these on the assigned TA and programs Leadership Demonstrate ability to work across functions regions and cultures Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization Train and develop less experienced staff with an awareness of mid- to long-term function goals and clinical development Interaction Cultivates a broad network of relationships throughout Takeda with affiliates and external partners in the industry and area of expertise Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner Innovation Recommend and influence the ideal model and approach for meeting the program goals and TA operational strategies Challenge status quo and bring forward innovative solutions Complexity Work in global ecosystem internal and external with a high degree of complexity Decision-making and Autonomy Provide input and implement appropriate strategies with understanding the goals of the function and assigned TA EDUCATION BEHAVIOURAL COMPETENCIES AND SKILLS Bachelor s Degree or international equivalent required Life Sciences preferred Innovate and challenge peers and teams to think and work differently Work independently excel at solving issues without the need for support but is effective at enlisting support for specific asks when necessary Participate and lead clinical operations in cross-functional initiatives and workstreams that affect clinical operations Adapt ways of working to the function s current state and formulate strategic plans to work within the existing framework Capable of assessing gaps cross-functionally and can take a supportive role in leading changes that benefits the function as it related to clinical trial execution and study management Encourage and provide input suggestions and support for competency building within the organization Demonstrated excellence in study management including scenario assessment risk assessment and contingency planning Excellent teamwork communication organizational interpersonal conflict resolution and problem-solving skills Talent development skills to enhance capabilities Experience of 10 years in pharmaceutical industry and or clinical research organization including 7 years of clinical study management oversight Experience must include Phase 1 2 3 studies and global international studies or programs Experience in more than one therapeutic area English fluently in oral and written communication Local language fluently a native level TRAVEL REQUIREMENTS Requires approximately 5-20 travel including overnight and local international travel to other Takeda sites strategic partners and therapeutic area required travel Locations IND - Bengaluru Worker Type Employee Worker Sub-Type Regular Time Type Full time