Senior Manager, Clinical Supply Chain Program Lead

Key Responsibilities

• Sets up the clinical supply chain strategy and strategic direction of supply for clinical programs
• Leads Clinical Supply Chain Managers/ Specialists responsible for the production, packaging, labelling and distribution of drug supplies for clinical studies, providing direction around study supply strategies, ensuring plans are appropriately aligned with business needs
• Ensures the supply chain strategy maximizes efficiency of supply, consistently balancing cost and risk
• Agregates the demand for Clinical program supply and ensures it is included in the Immunocore CMC and External Manufacturing supply planning process
• Produces and implements a Clinical Supply Chain Program Strategy document documenting the supply chain program strategy
• Implements continuous improvement aimed at scalability and applicability across programs
• Supports requests for supply for external sponsor studies, compassionate use and access programs, collaborating with and seeking expert input from cross functional subject matter experts (e.g., Regulatory Sciences, Clinical Sciences, Commercial) as necessary
• Makes sure the spend versus budget for clinical supply program activities and materials is monitored and communicated, leading Clinical Supply Chain and Finance review meetings and flagging variances
• Reviews changes to contracts with vendors and Contracts Manager if necessary
• May manage the procurement of IMP and ancillary materials as it relates to programs
• Manages and reviews inventory levels at manufacturing facilities, to ensure supplies are adequate according to the demand
• Provides support to ensure compliance with internal Quality Management system, including writing and reviewing SOPs
• When required, contributes to and reviews documents for submissions to regulators or ethics committees
• Contributes to and reviews supply and technical agreements, ensuring Quality oversight
• Initiates Quality Events where appropriate and investigates and performs root cause analysis and execution of associated CAPAs
• May deputize for the Senior Director, Clinical Supply Chain when absent as required
• Supports the selection of suppliers and assists with the preparation of documentation associated with the assessment, evaluation and management of CMOs, distribution depots and other contractors involved with clinical supplies
• Drives forward procedural change to improve compliance with SOPs/ regulations

Supervisory Responsibility

• Oversight of direct and indirect report(s) study execution and procedures as required to ensure regulatory compliance of protocol activities, if appropriate
• Accountable for ensuring all study supply deliverables and milestones are met with quality and within timelines
• Provides direction and support to direct and indirect report(s) to ensure consistent approach and process to study execution and procedures amongst various program assets
• Supports/escalates point for direct and indirect reports as needed

Experience & Knowledge

• Significant experience in the provision and management of clinical supply chains and associated activities
• Project management, and excellent organizational skills and attention to detail
• Strong interpersonal skills and effective communication with customers and partners
• Experience of cold chain supply management and biopharmaceuticals
• A thorough understanding of GxPs and the global regulatory requirements related to clinical supplies
• Demonstrated experience working with technical systems
• Experience working in a dynamic, matrix environment
• Experience working with managing and forecasting budgets
• Experience of drug usage forecasting/ supply and demand
• Experience in managing cross-functional aspects of project delivery
• Ability to work independently under general supervision

Education & Qualifications

• Degree or higher degree in a relevant scientific subject or business management, or equivalent relevant and appropriate industry experience
• Desirable: Masters or PhD in a relevant scientific subject
• Demonstrated computer skills; proven functional knowledge of Microsoft packages (MS Word, Excel, Power Point, Outlook, MS Project, SharePoint)

US Salary Range

$121,500-$202,500

About the Role

The Senior Manager, Clinical Supply Chain Program Lead will be a leader of cross-functional supply chain teams and representative of the Clinical Supply Chain function ensuring the effective management of drug production planning activities and the clinical supply chain, ensuring seamless provision of drug and ancillary supplies across the clinical portfolio.

As the primary Clinical Supply Chain contact with internal partners, the Senior Manager, Clinical Supply Chain Program Lead will work closely with Clinical Operation, Regulatory, Medical Affairs, Portfolio and Project Management and manufacturing colleagues to assist in the delivery of clinical supplies, while improving the use of resources in developing supply strategy within agreed time, volume, and cost, in line with relevant national and international requirements, ethical requirements and internal quality processes.

Benefits

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits.

Pay

US Salary Range: $121,500-$202,500

Schedule

N/A