Senior Clinical Supply Manager

Scancell; Oxford; Hybrid; GBP 70,000 - 110,000; Full time

Benefits offered by this job

Competitive salary

Employee benefits

Job summary

Scancell Ltd is seeking a Senior Clinical Supply Manager to provide strategic leadership and governance for clinical supply across the development portfolio. The role will oversee CRO relationships, establish KPIs, SLAs, and governance, and drive the transition of activities into a CRO-operated model while ensuring regulatory alignment and continuity of supply.

Working in a hybrid model, you will collaborate with CMC, QA, Clinical Operations, Regulatory and other internal teams to forecast

Job description

Post Title: Senior Clinical Supply Manager

Company: Scancell Ltd

Responsible To: Head of CMC

Location: Hybrid

Summary of Post

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 & Governance

• Provide strategic leadership, governance and Company-side oversight of clinical supply across the Company's development portfolio.
• Act as the Company's internal clinical supply lead and subject matter expert, providing strategic advice to programme and study teams.
• Develop and maintain the Company's overall clinical supply strategy and operating model, ensuring alignment with development strategy and portfolio requirements.
• Ensure the clinical supply operating model is fit for purpose, compliant, resilient and scalable as the Company progresses into later-phase development.
• Provide strategic oversight of clinical supply requirements across IMPs, ancillary supplies, medical devices and other study-specific materials, as applicable.

CRO Governance & External Partner Management

• Provide Company-side oversight of the CRO's clinical supply strategy, planning and delivery, ensuring appropriate operational execution against agreed requirements.
• Establish and maintain appropriate KPIs, SLAs, governance forums and performance-management mechanisms for the CRO.
• Monitor CRO performance against agreed scope, quality, timelines, budget, deliverables and service levels.
• Review and challenge CRO supply strategies and plans where required, ensuring they are appropriate to programme needs and risk.
• Manage the clinical supply relationship with the CRO at an operational, strategic and governance level, ensuring effective communication, accountability and escalation.
• Lead the escalation and resolution of significant CRO performance issues and clinical supply risks.
• Oversee the performance of other external clinical supply partners where relevant, ensuring appropriate alignment with the CRO operating model.
• Ensure clear accountabilities and interfaces between the Company, CRO and other external partners.

Supply Strategy, Planning & Risk Management

• Provide strategic oversight of clinical supply forecasting, demand and supply planning, ensuring alignment with clinical development plans, recruitment assumptions, dosing requirements and programme timelines.
• Ensure appropriate scenario planning and supply modelling is undertaken to support changes in study size, geographical scope, programme complexity and clinical demand.
• Oversee the development of appropriate inventory and supply-continuity strategies.
• Proactively identify, assess and manage clinical supply risks, dependencies and constraints.
• Establish appropriate risk mitigation, contingency and business continuity strategies to protect clinical programmes from supply disruption.
• Ensure significant supply risks and issues are appropriately escalated through programme governance and communicated to relevant stakeholders.
• Provide strategic oversight of supply readiness for study start-up, major study milestones and programme expansion.
• Lead the transition of relevant clinical supply activities from existing external vendor arrangements into the CRO operating model.
• Ensure appropriate knowledge transfer and effective implementation of transitioned activities.
• Ensure clinical supply processes and responsibilities are appropriately incorporated into the CRO's QMS and operating framework.
• Establish appropriate Company oversight and governance of activities delegated to the CRO.
• Identify and address gaps in the outsourced operating model as the Company's clinical development portfolio evolves.

Cross-Functional Leadership

• Work closely with CMC, QA, Clinical Operations, Regulatory, Programme Management and other internal functions to ensure clinical supply requirements are appropriately incorporated into programme and study planning.
• Provide clinical supply expertise and strategic input to development strategy, study design and programme planning.
• Assess the clinical supply implications of changes to development plans, study design, recruitment assumptions, manufacturing strategy and geographical scope.
• Ensure effective cross-functional communication and alignment on supply strategy, risks, dependencies and key decisions.
• Support programme governance and decision-making by providing clear assessment of clinical supply risks, opportunities and recommendations.

Continuous Improvement & Capability Development

• Drive continuous improvement of the Company's clinical supply processes, systems, governance and external partner-management practices.
• Identify opportunities to improve the efficiency, resilience, scalability and cost-effectiveness of the outsourced clinical supply model.
• Develop and evolve clinical supply governance, processes and systems in line with the Company's increasing scale and maturity.
• Ensure the clinical supply operating model remains appropriate for larger, more complex and later-phase clinical trials.
• Promote a culture of proactive risk management, operational excellence and continuous improvement.

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to changing business needs.

Further details about Scancell may be found at: www.scancell.co.uk .

Salary: Competitive salary and comprehensive employee benefits