Vacancy Name: Senior Manager Clinical Supply Chain Program Lead
Vacancy No: VN777
Employment Type: Full Time
Location of role: Gaithersburg, MD Radnor, PA
Department: Clinical Supply Chain
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 reports 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 reports to ensure consistent approach and process to study execution and procedures amongst various program assets • Provides supportescalation 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
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 industrys 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.