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
The Director, Global Clinical Operations (GCO) Functional Excellence (FxExc), will be responsible for leading and managing the GCO FxExc team. GCO FxExc ensures Daiichi Sankyo’s portfolio of clinical trials are executed consistently, efficiently, and with quality through leadership and project management of high priority workstreams and strategic imperatives focused on operational excellence, productivity, and digital transformation. The Director will also lead the FxExc team activities to support GCO innovation and optimization through understanding the external landscape and trending to shape the future of Daiichi Sankyo clinical trials. In addition, FxExc may be responsible for vetting and tracking GCO vendors in the future.
Job Description
Responsibilities
Process Improvement, Digital Innovation and Optimization (DI&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
- In close partnership with Clinical Trial Business Operations (CTBO), G-DIM, Dx, and other R&D partners, advance digital and data capabilities for the GCO organization.
- Serve as a key SME contributor in defining GCO digital strategy, solution development, and testing.
- Support adoption and scaling of digital and AI solutions across the GCO organization.
- 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 DI&O tools.
- 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.
Utilize strategic conferences for information mining and networking, engage more with organizations such as Transcelerate, WCG/Avoca, SCOPE, SCRS, DIA, etc.
GCO Training:
- 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, as appropriate.
- 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 initiative outcomes, digital solution introduction, and/or process improvements and rolls out GCO training and/or lessons learned, as appropriate. Identifies gaps and opportunities for improved performance.
Establish and oversee change management process to ensure foundational materials are up-to-date.
Responsibilities Continued
Metrics:
- Partner with Clinical Trial Business Operations (CTBO) to:
- Develop tools to track and monitor project statuses and reports progress regularly.
- Monitor GCO process improvements 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.
Present metrics and trend analysis to key stakeholders in Global Clinical Operations and GDO Leadership, as needed.
People Management:
- 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.
Qualifications
Bachelor's Degree Bachelor's degree with minimum of 10 years' experience in pharmaceutical or biotechnology across clinical trial operations. Experience in training, process improvement, and project management a plus. required
Experience Qualifications
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) required
Strong leadership, collaboration, influencing, and change management skills in a complex, matrix environment including team leadership or project management 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
Travel Requirements
Ability to travel up to 10% of the time. For team meetings, conferences and to support inspections, as appropriate..
Additional Information
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$198,160.00 - USD$297,240.00