Key Responsibilities:
- Set clinical supply chain strategy and supply direction for clinical programs
- Lead Clinical Supply Chain Managers/Specialists overseeing production, packaging, labeling, and distribution of drug supplies; ensure study supply plans align with business needs
- Maximize supply efficiency while balancing cost and risk
- Aggregate Clinical program supply demand and ensure inclusion in Immunocore CMC and External Manufacturing supply planning
- Produce and implement a Clinical Supply Chain Program Strategy document
- Implement continuous improvement for scalability and applicability across programs
- Support supply requests for external sponsor studies, compassionate use, and access programs; collaborate with SMEs (e.g., Regulatory Sciences, Clinical Sciences, Commercial)
- Monitor and communicate spend vs. budget; lead Clinical Supply Chain and Finance review meetings; flag variances
- Review vendor contract changes with the Contracts Manager as needed
- May manage procurement of IMP and ancillary materials
- Manage and review inventory levels at manufacturing facilities to meet demand
- Support compliance with the Quality Management system, including writing/reviewing SOPs
- Contribute to/reguIator and ethics committee submissions when required
- Contribute to/review supply and technical agreements with Quality oversight
- Initiate Quality Events as appropriate; conduct root cause analysis and execute CAPAs
- May deputize for Senior Director, Clinical Supply Chain when absent
- Support selection of suppliers and documentation for CMO/distribution depots/contractors
- Drive procedural changes to improve compliance with SOPs/regulations
Supervisory Responsibility:
- May include line management; ensure regulatory compliance and delivery of study supply milestones with quality and timelines
Experience & Knowledge:
Essential:
- Significant experience managing clinical supply chains
- Project management; strong organization and attention to detail
- Interpersonal skills and effective communication
- Cold chain supply management and biopharmaceutical experience
- Thorough understanding of GxPs and global clinical supply regulatory requirements
- Technical systems experience
- Experience in dynamic, matrix environment
- Experience managing and forecasting budgets; drug usage forecasting/supply and demand
- Cross-functional project delivery experience; ability to work independently
Desirable:
- Strong understanding of drug development process
- Technical experience delivering biopharmaceuticals to the clinic
- Experience across all clinical trial phases (including post-launch)
- Oncology therapeutic knowledge
Education & Qualifications:
- Degree (or higher) in a relevant scientific subject or business management, or equivalent industry experience
- Desirable: Masters or PhD in a relevant scientific subject
- Proficient with Microsoft tools (Word, Excel, PowerPoint, Outlook, MS Project, SharePoint)