Senior Director, Data Management

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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 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.   

Summary

Sr. Director Data Management contributes to the vision, direction and strategy for Data Management globally and executes the strategy regionally.  This position is responsible for regional performance of the function and the development of regional team members.  This position also monitors trends in functional performance via quality, time, and cost indicators, and makes recommendations for improvements.  Additionally, this position recommends and executes strategies in collaboration with Senior Management and global stakeholders that are optimized across business units, regions, and functional areas to ensure successful outcomes for projects/studies.

This position has advanced knowledge of Electronic Data Capture/related applications and industry standards, and advanced skills partnering with CROs and other third party vendors.  This position has excellent verbal/written skills, analytical, organizational, and interpersonal skills and collaborates effectively with stakeholders at different levels and from different disciplines and cultures. This position mentors/coaches within Data Management and cross-functionally. Additionally, this position possesses advanced knowledge of clinical operations and relevant regulatory requirements.  This position has advanced experience working on Phase I-IV studies within the medical device and/or pharmaceutical industry across multiple therapeutic areas and actively participates in regulatory submissions and inspections.  Finally, this position has advanced skills in continuous improvement, project management, change management, and risk management.

Responsibilities

Leadership, Direction, and Strategy:

• Contributes to the vision, direction and strategy for Data Management in support of the advancement of the global portfolio.
• Responsible for regional execution of the global strategy and performance of the function and regional team members.
• Leads a team and is responsible for performance management, coaching and development of team members.
• Acts as a Data Management point of contact for Senior Management and high-level internal and external stakeholders on global projects and/or programs
• Makes decisions and provides solutions that impact the function regionally and collaborates with relevant stakeholders to make recommendations/decisions that impact the function globally.
• Collaborates cross-functionally to resolve issues on programs and collaborates globally to resolve global issues.
• Liaises with other functions to ensure effective cross-functional communication throughout drug development process.
• Establishes and manages effective collaborations with external drug development partners by contributing to development of common standards and process via functional committees
• Proactively identifies and manages risks for the function regionally and supports functional risk identification/management efforts globally.

Project Management:

• Contributes to departmental resource planning, budgeting, and timeline setting.
• Monitors trends in departmental performance via quality, time, and cost indicators, and makes recommendations for improvements.
• Resolves and/or escalates issues encountered at the department level or cross-functionally.
• Provides the highest level of CRO/vendor oversight to ensure project plans are executed properly (e.g., operational leadership teams) and quality deliverables are achieved on time and budget.

Functional Expertise:

• Serves as a Data Management expert regionally/globally.
• Acts as coach/mentor at the department level and regional Data Management expert.
• Collaborates cross-functionally during interactions with Regulatory Authorities and other key external stakeholders (e.g., advisory committees and integration teams).