Associate Director, Clinical Program Management

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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.