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 Director, Global Clinical Operations (GCO) Functional Excellence (FxExc), will be responsible for leading and managing the GCO functional excellence team to include, but not limited to project management of workstreams and strategic imperatives, training and onboarding activities. The Director will also lead the FxExc team activities to support GCO innovation and optimization by gathering industry expertise and trending to shape the future of Daiichi Sankyo clinical trials. In addition, FxExc will be responsible for vetting and tracking GCO vendors and assessment status.
Process Improvement, Innovation and Optimization (I&O):
- Own and oversee project management (PM) of R&D level workstreams where GCO participates, Strategic Imperatives (SIs) and process improvement workstreams, partnering with cross-functional subject matter experts.
- Prioritizes tasks and establishes action plans to support execution of improvement projects.
- Presents performance results in visualizations and dashboards to enable Leadership to make informed decisions.
- Serves as GCO SME on improvement projects and compliance with deadlines to achieve desired outcomes.
- Partner and collaborate with other FxExc teams within Daiichi Sankyo to optimize cross-functional synergies and improvements.
- Work with subject matter experts to determine needs and build business cases for implementation of I&O tools.
- Oversight of FxExc team managing the vetting of GCO vendors, and tracking GCO vendor assessments and final choices, in collaboration with R&D Procurement, who leads the vendor assessment process.
- Provide oversight of the FxExc team helping other GCO functional roles in the creation and/or maintenance of templates (tools, guidance documents, execution plans, Visio and/or Project process mapping), and/or Power Point presentations, as needed.
- Build industry expertise in innovation and optimization for clinical trials.
- o Utilize strategic conferences for information mining and networking, engage more with organizations such as Transcelerate, WCG/Avoca, SCOPE, SCRS, DIA, etc.
- Provide oversight of the FxExc team in the creation and/or maintenance of GCO Onboarding training, as well as providing oversight and management of the GCO
- training curriculum in collaboration with Clinical Quality Management and/or QA.
- Lead and/or support identification and implementation of learning and training related needs within GCO. Liaise with other functions and stakeholders, as needed.
- Reviews SOPs and training documentation resulting from new processes or process improvements and rolls out GCO training and/or lessons learned, as
- appropriate. Identify gaps and opportunities for improved performance.
- Establish and oversee change management process to ensure foundational materials are up to date
- Partner with Clinical Trial Business Operations (CTBO) to:
- Develop tools to track and monitor project statuses and reports progress regularly
- Monitor GCO processes and workstream implementations for effectiveness
- Monitor key metrics and partners 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.
- Present metrics and trend analysis to key stakeholders in Global Clinical Operations and GDO Leadership, as needed
- Responsible for the continued FxExc strategy build, and to create clear objectives and goals for the team in alignment with the growth and advancement of Daiichi Sankyo to support business needs.
- Conduct performance evaluations against goals for direct reports.
- Coach and guide their functional and/or direct reports in support of their development needs, and provide real-time feedback on job performance
- Develop plan for resourcing of activities within remit/scope. Ensure appropriate resources (employee and/or contractor-based) are available to support current
- and future clinical programs and studies.
- Drive a feedback-oriented culture
Bachelor's degree required with minimum of 10 years' experience in pharmaceutical or biotechnology across clinical trial operations required.
Experience in training, process improvement, and project management a plus.
Deep 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)
Strong leadership, collaboration, influencing, and change management skills in a complex, matrix environment including team leadership or project management is required.
Experience in clinical trial process 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 - required.
Understanding of industry trends (e.g., regulatory, technology) with ability to apply them to process improvements - required.
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.