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.
About the role
As Director, Company Sponsored Studies (CSS) within Global Oncology Medical Affairs (GOMA), you will lead the operational strategy and execution of global company-sponsored interventional and non-interventional studies and medical affairs research projects in oncology. Acting as Study Lead, you will drive study delivery from planning through close-out, ensuring compliance, quality, timelines, and budget adherence while working in a highly collaborative, cross-functional, global matrix environment.
The position can be filled at one of our European affiliates (including Canada; with a preference for placement in Germany) or the US.
Key Responsibilities
- Lead the operational planning, execution, and delivery of global oncology company-sponsored interventional and non-interventional studies and medical affairs research projects, ensuring compliance with GCP, regulatory requirements, DS policies, timelines, budgets, and quality standards
- Serve as Global Study Lead, driving cross-functional, global study teams and coordinating all relevant activities across Medical Affairs, Clinical Operations, Regulatory Affairs, Safety, Data Management, Stats., Quality, etc. as well as with external partners
- Oversee and direct CROs and external vendors from selection through study completion, ensuring effective and compliant performance management, risk mitigation, budget oversight, and high quality delivery of milestones and study objectives
- Provide strategic and operational leadership throughout the study lifecycle, including study planning, protocol development support, study start-up, execution, and final study reporting
- Represent the GOMA Company Sponsored Studies (CSS) group on global asset, program and study teams, acting as the primary point of contact for GOMA clinical operational activities and collaborating closely with internal functional teams, alliance partners and regional stakeholders
- Drive continuous improvement of clinical operations processes, systems, SOPs, and quality standards to enhance GOMA study execution and operational excellence across GOMA
- Identify, assess, and proactively manage study and program risks, ensuring appropriate mitigation strategies and effective escalation of critical issues
Qualifications
- Master's degree in Life Sciences is required; PhD or PharmD preferred
- Minimum of 8 years strong GxP related, international clinical operations experience in a global pharmaceutical company, and/or Contract Research Organization (CRO), preferrably within Oncology environment
- Proven experience leading global interventional and non-interventional clinical studies and working within Medical Affairs units
- Excellent knowledge of GCP, global clinical trial regulations, vendor oversight, and study management
- Self-responsibility with excellent project leadership, stakeholder management, and communication skills
- Ability to thrive in a global, cross-functional matrix organization
- Professional English, written and spoken
