Clinical Supply Chain Program Lead
Immunocore

Job Info

---

About the CompanyImmunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

We strive to create a diverse and inclusive workplace, while seeking talented individuals to work with us across the many functions that will allow us to deliver new medicines to transform the lives of patients. You will work with outstanding people who together pioneer the research, development and commercialization of bi-specific TCR therapies. We aim to create an environment where individual contributions and initiatives can be maximized, while fostering a culture of collaboration, based on respect and integrity. We want each individual employee to own their career, as part of high-performing teams, and in the context of on-the-job and formal continuous development and training, as well as constructive feedback. We always strive to identify ways to improve what we do and how we do it, by asking questions, voicing opinions, exploring various approaches and staying connected with healthcare professionals, patients, academia and other key partners. Key ResponsibilitiesThe 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 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.
Responsibilities:

• Sets up the clinical supply chain strategy and strategic direction of supply for clinical programs
• Leads Clinical Supply Chain Managers 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
• Aggregates 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.
• Monitors and is responsible for communicating the spend versus budget for clinical supply program activities and materials, leads Clinical Supply Chain and Finance review meetings and flags 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 investigate and perform root cause analysis and execution of associated CAPAs.
• May deputize for the Head of Clinical Supplies when absent as required.
• Supports the selection of suppliers and assist 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.

This position may include line manager responsibilities:
• 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.
• Provide direction and support to direct and indirect report(s) to ensure consistent approach and process to study execution and procedures amongst various program assets.
• Provides support/escalation point for direct and indirect reports as needed

Essential:
• 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.

Desirable:
• Strong understanding of the drug development process.
• Experience in technical aspects of delivering biopharmaceutical products to the clinic.
• Worked in all phases of clinical trials, including post-launch.
• Knowledge and experience in Oncology therapeutic discipline.
• Experience working in a dynamic environment and collaborating with cross-functional teams to deliver complex projects.

• Bachelor's 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).

This job has expired.