Study Delivery Lead; SDL

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.

The Study Delivery Lead (SDL) leads the cross functional core and extended clinical study team in end-to end delivery of the clinical trial with consistency, quality and per planned timelines. The SDL has the accountability for 1 or several complex studies in various settings including Phase I-III, within a delivery model comprising of outsourced studies or outsourced studies with elements of in sourcing.

This includes global operational execution and delivery of clinical studies across multiple geographic regions, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Health Authority regulations, International Conference on Harmonization (ICH) guidelines and local regulations, as required. The SDL is accountable for operational planning and execution at the study level with responsibility for clinical study plans and execution (from planning start-up, conduct, reporting and close out) including timeline, and budget.

The SDL will partner with the Strategic Vendor Oversight (SVO) team and collaborate with the core and extended team to ensure robust CRO oversight including 3rd party vendors to achieve study milestones and deliverables according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission. The SDL collaborates with cross-functional stakeholders and the Metrics, Analytics, Reporting and Solutions (MARS) team to drive and monitor progress.

The SDL fosters an environment where the core study team maximizes their expertise and contribution to trial delivery, including but not limited to issue resolution, risk mitigation and escalation to Global Project Team (GPT), SCORE and other governance level as needed. The SDL will have regular interactions with key internal and external stakeholders to discuss project status, escalate issues, and troubleshoot inquiries.

For this role, strong written and verbal communication skills in English, operational leadership, and decision-making, ability to delegate, strategic thinking, conflict resolution, clinical project management experience and attention to detail are required. The SDL is an experience matrix leader and serves as a mentor to more junior colleagues on clinical trial execution. Outside interfaces may include other Daiichi-Sankyo business groups and subsidiaries in the US and abroad, governmental, academic, community and industry organizations.

The SDL is the reference and role model within the study delivery lead team that drives the culture for a healthy team. The role is primarily responsible for Operational Study Strategy and Study Execution while exhibiting leadership qualities.

Lead the core study team while project managing and collaborating with internal stakeholders to ensure cross functional integration and delivery of study milestones (e.g. protocol, eCRF/EDC, IXRS, Clinical Study Oversight Plan etc.)

• Ensure operational study-level timeline, budget, deliverables and quality management
• Facilitate escalation and resolution of issues with CRO/ vendors/ site/ country performance raised by the study team, including serious quality incidents and serious breaches of GCP. The SDL is accountable for escalation to the OPL/Asset Lead (or Senior Line Leaders in the absence of Asset Lead).
• Where appropriate, may delegate certain responsibilities to Study Manager(s) assigned to the study Protocol Development, and Team Assembly
• Contribute to and interface with different levels of study governance, as required
• Oversee the development of the clinical study plan including critical path activities and interdependencies for assigned clinical stud(ies)
• Provide operational input into concepts, CDP, study protocol profiles, final protocols and amendments
• Participate in protocol and amendment review.
• Contribute to the development of and oversee delivery timelines of ICF, IB and safety communications, DSUR, IND.
• Partner with other functional leaders to address core study team gaps and ensures accurate and complete study team list is maintained.
• In partnership with the lead physician, Clinical Scientist and all study team members, accountable for the co-ordination and conduct of feasibility process for protocol development in alignment with the CDP/IEP. Application of feasibility analysis to manage study implementation in the clinical and regulatory environment across participating regions,…