Key Responsibilities
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.
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
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 Senior Director, Clinical Supply Chain 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
SUPERVISORY RESPONSIBILITY
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
Experience & knowledge
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.
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 Company
Immunocore (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.
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.
Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.
