Key ResponsibilitiesThe Manager, Clinical Supply Chain role will ensure the effective management of drug manufacturing and the clinical supply chain, ensuring seamless provision of drug and ancillary supplies across the clinical portfolio. The Manager, Clinical Supply Chain will work closely with internal clinical supply chain, clinical operation, regulatory and manufacturing colleagues to assist in the delivery of clinical supplies in line with related regulatory requirements and internal quality processes. This onsite role can be located at our Abingdon, UK office or in the US at either our Gaithersburg, MD or Conshohocken, PA locations.
KEY RESPONSIBILITIES
Leads and provides direction around Supply Chain discussions in team meetings, having effective communication with customers and partners
Sets up the clinical supply chain strategy for studies and/or clinical portfolio of studies.
Designs and implements labelling, packaging and supply strategies that not only meet the requirements of the study design, the clinical study sites and the relevant regulatory authorities, but also maximizes efficiency of supply
Manages, with input from CMC and Regulatory groups, the generation and approval of label texts, translations (where required) and label proofs
Produces a clinical supply agreement document documenting the agreed supply option providing details of the design, setup and how the supply chain will operate for responsible studies or group of studies
Ensures a supply chain strategy delivers clinical supplies effectively and consistently balancing cost and risk to supply
Seeks out expert input and support from cross functional groups
Understands and translates clinical protocol requirements into demand for study and where applicable aggregates demand for program of studies
Monitors the budget for individual study and program activities and materials, contributes to Clinical Supply Chain and Finance review meetings and flags deviations
Reviews changes to contracts with vendors and Contracts Manager if necessary
Works with other Clinical Supply Chain team members to resolve issues, share best practice and continually develop competence
Serves as point of contact and manage relationships with IRT, packaging, labelling and distribution vendors
Manages labelling, packaging and distribution activities including review and approval of labelling/packaging records and distribution plans
Manages the procurement and distribution of IMP and ancillary materials ensuring that all study specific regulatory requirements are met
Ensuring seamless provision of supplies by carrying out activities such as:
o Management of drug temperature excursions during shipment and storage
o Drug usage forecasting across the clinical portfolio
o Contributing to the design and testing of IRT systems during study setup
o Administration and Monitoring of IRT systems for drug supply demands
o Arranging and monitoring depot and site shipments as required
o Troubleshooting site clinical pharmacy issues
o Management of shelf-life/expiry updates of all clinical supplies
o Management of activities relating to the accountability, reconciliation, return and destruction clinical supplies
o Management and review of inventory levels at manufacturing facilities, distribution hubs and local depots to ensure supplies are adequate according to the demand
Ensures that clinical supplies related documentation is filed appropriately, i.e. within the Trial Master File or the lmmunocore controlled filing system, ensuring records are inspection ready and compliant with regulations
Supports in preparing, reviewing and formatting support documents for clinical trials, including pharmacy handling instructions, pharmacy manual, distribution project specifications etc.
Provides support to ensure compliance with lmmunocore's Quality Management system, including writing and reviewing SOPs
When required, contributes to andreviews documents for submissions to regulators or ethics committees
Presents and trains on clinical supply material to clinical trial personnel or at investigators meetings as necessary. This may involve travelling nationally and internationally for face-to-face training when required.
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
Assists with troubleshooting site clinical pharmacy issues as needed
Deputize for the Director or Sr. Manager Clinical Supply Chain when absent as required
Provides guidance to more junior clinical supply chain personnel
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 trial supplies
Drives forward procedural change to improve compliance with SOPs/ regulations
This position may include line manager responsibilities
Oversight of direct report(s) study execution and procedures as required to ensure regulatory compliance of protocol activities, if appropriate
Accountable for ensuring all study deliverables and milestones are met with quality and within timelines
Provide direction and support to direct report(s) to ensure consistent approach and process to study execution and procedures amongst various program assets
Provides support/escalation point for direct reports as needed
Experience & knowledge
Essential
Significant experience in the provision and management of clinical trial supplies and associated activities
Project Management skills
Experience of cold chain supply management and biopharmaceuticals
Experience of design, testing, implementation and management of IRT systems for multi-regional studies
Excellent attention to detail.
Strong interpersonal skills with experience of managing external CROs
A thorough understanding of GxPs and the global regulatory requirements relating to the labelling and supply of clinical supplies
Excellent organizational and computer skills (Word, Excel, PowerPoint, Outlook)
Experience working in a matrix environment
Experience working with managing and forecasting budgets
Desirable
Worked in all phases of clinical trials, including post-launch
Knowledge and experience in Oncology therapeutic discipline
Experience of drug usage forecasting/ supply and demand
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)
Work authorization and a valid passport is required for this role. Limited overnight travel is expected with some international and local travel required. Approximately up to 5 % travel.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 medici
