At a Glance
- Tasks: Lead clinical supply strategy and oversee CRO operations for clinical development.
- Company: Join Scancell Ltd, a pioneering company in clinical research.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Dynamic role with opportunities to innovate and improve clinical supply processes.
- Why this job: Make a significant impact on clinical trials and patient outcomes.
- Qualifications: Experience in clinical supply management and strong leadership skills.
The predicted salary is between 49500 - 60500 £ per year.
The Senior Clinical Supply Manager will provide strategic leadership, governance and Company-side oversight of clinical supply across the Company’s development portfolio. The role will be accountable for establishing and maintaining a robust, scalable and compliant clinical supply operating model that supports the Company’s transition from early- to late-phase clinical development and the increasing scale and complexity of its development programmes.
Operating within an outsourced model, with the CRO responsible for the operational execution of clinical supply activities, the post holder will provide oversight and governance of the CRO’s clinical supply strategy, planning and delivery. The role will ensure that the CRO has appropriate processes, capabilities, resources and controls in place to deliver clinical supply requirements in line with programme strategy, clinical development plans, study requirements, timelines and agreed quality and regulatory expectations.
The post holder will provide strategic oversight of clinical supply planning across IMPs, ancillary supplies, medical devices and other study-specific materials, as applicable. This will include oversight of forecasting, demand and supply planning, inventory strategy, supply continuity and operational readiness, while ensuring that detailed operational execution remains appropriately delegated to the CRO and other service providers.
A key responsibility will be management and governance of the clinical supply relationship with the CRO, including oversight of performance, service levels, timelines, budgets, deliverables, quality and governance. The post holder will establish appropriate KPIs, SLAs and governance mechanisms, monitor CRO performance and proactively address significant performance issues, risks and dependencies.
The post holder will lead the escalation and resolution of material clinical supply issues, ensuring timely decision-making and effective communication across internal stakeholders and external partners. The post holder will lead the transition of relevant clinical supply activities from the Company’s existing external vendor arrangements into the CRO operating model. This will include establishing clear roles, responsibilities, processes, interfaces and governance arrangements, ensuring effective knowledge transfer and implementation within the CRO’s QMS and operating framework, while maintaining appropriate Company oversight.
Working closely with CMC, QA, Clinical Operations, Regulatory and other internal functions, the post holder will provide clinical supply expertise to programme and study planning and ensure that supply considerations are appropriately incorporated into development strategies, study plans and clinical timelines. The role will identify supply implications and risks associated with programme changes, study design, recruitment assumptions and geographical expansion, and ensure appropriate mitigation and contingency strategies are established.
The post holder will also drive the ongoing development and continuous improvement of the Company’s clinical supply operating model, processes, systems and governance. This will include identifying opportunities to improve the resilience, efficiency, scalability and cost-effectiveness of the outsourced model and ensuring that it evolves in line with the Company’s progression towards larger, more complex and later-phase clinical trials.
Key duties and responsibilities
Clinical Supply Strategy
Senior Clinical Supply Manager employer: Scancell
Scancell is an exceptional employer located in the vibrant Oxford Science Park, offering a dynamic work environment that fosters innovation and collaboration. As an Associate Scientist, you will be part of a dedicated team contributing to groundbreaking cancer vaccine therapies, with access to comprehensive employee benefits and opportunities for professional growth. The company's commitment to scientific excellence and supportive culture makes it an ideal place for those seeking meaningful and rewarding careers in the life sciences sector.
