At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
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). This includes overseeing the whole clinical supply to support total performance of clinical development in not only oncology but also specialty medicine therapeutic area. This position manages CSO functions in DST, DSI, and DSE and has direct reporting lines from those functions. This position serves as a strategic CSO lead for all global development projects in cooperation with clinicals in R&D, Oncology Business Unit (OBU), Quality & Safety Management, Supply Chain, and other relevant global functions.
The position is also responsible for comparator management, especially for oncology projects at the global level. The remit includes to be responsible for establishment, governance and oversight of all clinical supply vendors including, but not limited to, Interactive Response Technology (IRT), labeling, distribution, storage, transfer and destruction. This position supports the Head of Supply Chain Mgmt (SCM) to represent its function at the Technology Unit Steering Committee (TUSC), GPAD, and other decision-making bodies in Daiichi Sankyo Group for making the best decision.
This position also helps the Head of Project Lead to be a member of Supply Chain Committee with AstraZeneca (AZ) & Merck Sharp & Dohme (MSD) collaborations. Additionally, as the regional head of DSI (US) CSO, this position will 1) Oversee all the Clinical Supply Operation-related functions in DSI, 2) Ensure alignment between DSI-CSO and TECH Unit sub-functions (Project Lead (CMC), Regulatory Affairs CMC, Process Technology Research, Formulation Technology Research, and Analytical & Quality Evaluation Research), 3) Make the best effort to increase the total performance of the TECH Unit. The individual in this position requires an advanced level of executive leadership and demonstrates the capability of managing complex relationships among the wide-range stakeholders in the US, Japan, and the EU including both therapeutic areas (Oncology and Specialty Medicine) in R&D and Global Medical Affairs.
The position needs to collaborate very closely with various executives in DSI and other legal entitites across Daiichi Sankyo Group. This position will drive organizational changes in alignment with Daiichi Sankyo Group's 2030 Vision and ensure high levels of employees' engagement and productivity.
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 minimalizing 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, participate 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
Travel Requirements
Ability to travel up to 20% of the time. Domestic and International Travel (Japan, Germany, China)
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range:
USD$255,000.00 - USD$425,000.00