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. 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 Manager, Business Process Engineer, will partner with functional leaders and process owners to shape and execute a continuous improvement plan for end-to-end clinical trial processes. This includes monitoring process metrics, identifying areas for improvement, and designing and implementing process improvements.
* Partners with functional leaders and process owners to design and implement a clear, well-defined process with clear inputs, outputs, and roles & responsibilities - integrates people, process, and technology components of process design
* Participate on cross-functional process improvement teams/workstreams tasked with re-designing or improving processes including providing input to timeline for process improvement projects
* Develops process maps and other process documentation to facilitate the team's analysis and optimization of processes.
* Assists Process Owner with change management and implementation of process improvements
* Keep Global R&D SOP Office and other relevant SOP committees informed of new processes or process updates requiring SOP updates. Reviews SOPs and training documentation resulting from these new processes or process improvements.
* Monitor key metrics/KPIs/KCIs and partners with Process Owner to identify and address gaps/deficiencies
* Work with Process Owners to develop process optimization plans and priorities for review by Process Sponsors and Process Council. Facilitate periodic Process Council review and prioritization of process optimization plans within and across process groups
* Works with CRO Alliance Managers and CRO partners to ensure optimization of key process interfaces to ensure seamless integration of internal and external activities
* Works with Process Owner to capture and communicate Lessons Learned
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
* Bachelor's Degree is required, with 4 or More Years In pharmaceutical or biotechnology drug development is preferred
* PharmD with minimum of 1 year of experience in pharmaceutical or biotechnology drug development preferred
* PhD with minimum of 1 year of experience in pharmaceutical or biotechnology drug development preferred
* 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, project management) preferred
* Leadership, collaboration, and influencing skills in a complex, matrix environment including team leadership or project management preferred
* Experience in clinical trial process design, harmonization/optimization, and implementation preferred
* Understanding of industry trends (e.g., regulatory, technology) with ability to apply them to process improvements preferred
* Six Sigma certification and/or experience with process mapping tools (e.g., Visio, Power Point) desirable preferred
Ability to travel up to 10%
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.
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- Business Processes
- Change Management
- Clinical Research
- Clinical Trials