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 16,000 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.
Summary
The Manager, Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support and may manage day to day functional excellence activities to include, but not limited to, the project management of workstreams and strategic imperatives, training and onboarding, metrics activities, participate in GCO vendor assessment, and tracking od vendors and assessment status. In addition, this role will support the FxExc Director in lead innovation and optimization by gathering industry expertise and trending to shape the future of Daiichi Sankyo clinical trials.
Responsibilities
- Process Improvement, Innovation and Optimization (IO):-Project manage GCO Strategic Imperatives (SIs) and process improvement workstreams, partnering with cross-functional subject matter experts.-Support the build of industry expertise in innovation and optimization for clinical trials.-Utilize strategic conferences for information mining and networking, engage more with organizations such as Transcelerate, WCG/Avoca, SCOPE, SCRS, DIA, etc.-Work with and/or support subject matter experts to determine needs and build business cases for implementation of IO tools.-Assist with the tracking of vendors - vendor assessment status and final choices, in collaboration with RD Procurement, who leads the vendor assessment process.-Participate with other FxExc teams within Daiichi Sankyo to optimize cross-functional improvements.-Support creation and/or maintenance of templates (tools, guidance documents, execution plans, Visio and/or Project process mapping), and/or Power Pointpresentations, as needed.
- GCO Training:-Contribute to the creation and/or maintenance of GCO Onboarding training.-Assist with the maintenance of the GCO training curriculum in collaboration with Clinical Quality Management and/or QA, as appropriate.-Participate with the identification and implementation of learning and training related needs within GCO. Liaise with other functions and stakeholders, asneeded.-Assist with the review of SOPs and training documentation resulting from new processes or process improvements and roll out GCO training and/or lessons learned, as appropriate.
- Metrics:-When needed, help support the partnership with Clinical Trial Business Operations (CTBO)to:-monitor GCO processes and workstream implementations for effectiveness.-monitor key metrics and partner with process owners to identify and address gaps/deficiencies, as needed.-track and oversee the progress of GCO initiatives and goals through KPIs and metrics to monitor and evaluate risks/issues across GCO and effectiveness of initiative and/or process implementation.-Work closely with CTBO and Alliance Management to respond to process metrics and trending data to identify gaps, and design/implement process improvements.-monitor and evaluate risks/issues across GCO initiatives
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 Bachelor's degree with minimum of 5 years' experience in pharmaceutical or biotechnology across clinical trial operations. Experience in training, process improvement, and project management required
Experience Qualifications
- 4 or More Years Experience 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) required
- Collaboration, influencing, and change management skills in a complex, matrix environment including project management preferred
- Experience in clinical trial design and improvement activities, harmonization/optimization, and training and implementation required
- Six Sigma certification and/or experience with process mapping tools (e.g., Visio, Power Point), training systems, and metrics dashboarding preferred
- Understanding of industry trends (e.g., regulatory, technology) with ability to apply them to process improvements preferred
Travel
Ability to travel up to 10%. For team meetings, conferences, and to support inspections, as appropriate.
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.