Executive Director, Head of Clinical Supply Planning and Operations SCM

Job Summary

Responsible for leading all Clinical Supply Operation (CSO)-related activities for oncology and specialty medicine drug candidates from early development to launch and life cycle management of products globally to achieve the business success of Daiichi Sankyo Group and managing the Global-CSO function from Daiichi Sankyo Inc. (DSI).

Responsibilities

• Defines and prioritizes goals, activities, and timelines to deliver on objectives. Leads the strategy for Global CSO, which includes alignment with the global, strategic vision and goal setting, global collaboration, and development of the functional capability. Also leads the vision for Global CSO in alignment with TECH Unit 2030 vision and Daiichi Sankyo Group’s 2030 Vision.
• Ensures stable operation of Clinical Trial Materials (CTM) and comparator management to secure robust supply. Saves the cost of expensive comparators by minimizing obsolescence of unused comparators. Interfaces closely with internal Clinical Supply partners such as Clinical Operations, Clinical Development, Quality, Regulatory Affairs and External Vendors to ensure that CTM is available as required. Collaborates continuously with Project Lead (CMC) to overcome changes in manufacturing plan that impact CTM supply.
• Develops and manages Global CSO strategies for all DS projects as the Head of Global CSO and accelerate product launches.
• Manages CSO functions in DSI, DST, and DSE, through direct reporting lines and manages/coordinates all the CSO-related activities including clinical supply delivery with packaging and labeling, inventory and logistics for all projects globally from early to late development. Key goals are met on time to supply CTMs and comparators without delay. As a part of the SCM-Committee, participates in SCM decision-making processes in cooperation with the Head of SCM Unit.
• Selects, maintains, develops, and motivates all the staffs in Global-CSO/DSI-CSO who can maintain Daiichi Sankyo’s quality and compliance mindset while transforming into an organization that can fulfill Daiichi Sankyo Group’s 2030 Vision, and demonstrates the short- and long-term growth of the company.
• Directs DSI-CSO organizational activities, establish priorities, schedule, and track work assignments, provides guidance, and ensures resource availability as a part of global organizations reporting to Head of SCM. Sets and executes the annual Global-CSO/DSI-CSO objectives with ensuring cascade down to each individual of DSI-CSO. Prepares and be accountable for annual Global-CSO/DSI-CSO budget including comparators through adequately manage expense projections and transparent reporting to the Head of SCM.
• Supports financial planning for clinical trials including budgeting, forecasting and strategic planning for clinical trials with finance staff to maximize productivity, efficiency and overall business performance.
• Establishes and maintain effective communication and collaboration with executives / senior management across the Global TECH UNIT Unit to meet department / corporate goals and serve as a cross-functional leader with a wide range of stakeholders. Builds strong partnerships with the Project Lead, Global Project Leader (GTL) in R&D, and DSI executives to maximize the value of DS’s portfolio.

Qualifications

• Education Qualifications: Bachelor's Degree preferably in a scientific or technical disicipline required. A Master's Degree in Chemistry, Life Sciences, Engineering, in Pharmaceutical or related discipline or a PhD preferred
• Experience Qualifications: Minimum of 15 years industry experience of relevant biotechnology or pharmaceutical industry (Clinical Supply Operations). 12+ years of experience in Clinical Supply Operation or a related pharmaceutical development field globally. Highly experienced working in oncology project development and in cold chain management. Experience in effectively managing cross-functional teams in a matrix organization. Required