Daiichi Sankyo Inc. Senior Director, Process Excellence & CRO Alliance Mgmt in Basking Ridge, New Jersey
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Join a Legacy of Innovation 110 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
The Senior Director, Process Excellence & Standards will set strategy and direction for the Process Excellence & Standards organization within Global Clinical Operations & Planning and play a key role in implementing and maintaining a continuous process improvement framework for the design and implementation of end-to-end clinical trial processes including rollout of a Process Council, kick-off of cross-functional Process Teams, and implementation of new roles (Process Owner and Process Manager/Specialist). Under the leadership of the Sr. Director, the Process Excellence & Standards group will also be responsible for developing process documentation and SOPs, GCP training and broader Learning and Development activities, metrics & benchmarking, and clinical quality management including tracking of GCP deviations/nonconformances, CAPA management, and inspection readiness.
Set strategy and direction for the Process Excellence & Standards Center of Excellence within Global Clinical Operations & Planning encompassing business process management, training, and clinical quality management
Partner with functional leaders and Process Owners to shape and implement a continuous process improvement (CPI) framework for end-to-end clinical trial processes including rollout of Process Council, kick-off of Process Teams, and implementation of Process Owner and Process Manager/Specialist roles
Serve as Chief of Staff for the Process Council, working with the committee chairs, members, and Process Teams to facilitate high-level governance of process improvement (strategy, prioritization, guidance, support and issue resolution) and maintenance of a continuous improvement plan for DS’s portfolio of processes
Establish a Process Owner/Process Manager forum to drive the change to CPI model and ensure consistency/connectivity across processes. In addition, keeps abreast of changes in industry/regulatory environment and regulations that would necessitate future changes to processes and proactively initiates discussions and process changes
Work with Process Managers and Metrics/Benchmarking lead to ensure that appropriate process performance metrics are maintained and actively deployed to diagnose and address process gaps/deficiencies
Support the efforts of Process Owners/Process Managers to drive change management and implementation of major process design changes
Partner with QA to ensure that clinical SOPs and GCP training are up-to-date, GCP deviations/nonconformances are tracked and addressed, and to ensure inspection readiness and CAPA management for items under GCO responsibility
Shape training and development strategies of GCOP staff through deployment of a GCO training center of excellence
Recruit, train, coach and develop staff to ensure development and deployment of key capabilities
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Bachelor’s Degree with minimum of 10 years’ experience in pharmaceutical or biotechnology drug development.
Significant experience and expertise in end-to-end clinical trial processes including experience in one or more key functions (e.g., clinical research, clinical operations, data management, biostatistics, clinical QA)
Understanding of industry trends (e.g., regulatory, technology) with ability to apply them to process improvements
Strong leadership, collaboration, and influencing skills including team leadership or functional management
Experience in clinical trial process design, harmonization/optimization, process implementation, and change management
Knowledge and understanding of GCPs and applicable regulatory guidelines governing clinical trials and clinical quality management
Experience with delivering presentations before executive staff
Previous experience working in cross-functional study teams/ projects and/or ability to establish and manage relationships
Effective and influential communication, self-management, problem solving and organizational skills
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.
Senior Director, Process Excellence & CRO Alliance Mgmt
Global Clinical Operations & Planning