Key Responsibilities
The Senior Specialist, 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 Senior Specialist, 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.
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 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
Monitors the performance of the supply chain strategy and optimizes it balancing speed quality and cost with respect to agreed level of risk (especially for higher volume phases)
Serve 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 a seamless provision of supplies by carrying out activities such as:
Management of drug temperature excursions during shipment and storage
Drug usage forecasting across the clinical portfolio
Contributing to the design and testing of IRT systems during study setup
Administration and Monitoring of IRT systems for drug supply demands
Arranging and monitoring depot and site shipments as required
Troubleshooting site clinical pharmacy issues
Management of shelf-life/expiry updates of all clinical supplies
Management of activities relating to the accountability, reconciliation, return and destruction clinical supplies
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 documents for clinical trials, including pharmacy handling instructions, pharmacy manual, distribution project specifications etc.
Provides support to ensure compliance with Immunocore's Quality Management system, including writing and reviewingSOPs
When required, contributes to and reviewing documents for submissions to regulators or ethics committees
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
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 review supply and technical agreements, ensuring Quality oversight
Provides guidance to more junior clinical supply chain personnel
Initiates Quality Events where appropriate and investigate and perform root cause analysis and execution of associated CAPAs
Experience & knowledge
Essential
Worked within pharmaceutical quality systems with an excellent understanding of the principles of "good practice"
Extensive industry experience in drug development
Worked collaboratively with existing teams
Worked to foster support and influence study stakeholders throughout the life of a project
Worked to meet deadlines on time, to scope and to budget
Worked to an exceptional standard regarding organizational skills
A proven track record of successfully contributing to the successful running of clinical study projects in a pharmaceutical/biotech business environment
Desirable
Experience of design, testing, implementation and management of IRT systems for multi-regional studies
Strong interpersonal skills with experience of managing external CROs ? Worked in early phase clinical trials ? Knowledge and experience in Oncology therapeutic discipline ? Worked in GMP or clinical supplies ? Knowledge of the Industry/Clinical trial process and drug development
Knowledge of ICH GCP
Experience of drug usage forecasting / supply and demand
Experience working in a matrix environment
Experience working with managing and forecasting budgets
ESSENTIAL COMPETENCIES
Communication Proficiency in local language
Must work with professional discretion and confidentiality
High Prioritization
Self-motivated- able to work autonomously
Able to anticipate challenges and devise strategies for success
Result and deadline orientated
Time Management
Collaboration Skills, and ability to work as part of a diverse team
Excellent presentation skills
Personal Effectiveness/Credibility
Flexibility
Technical Capacity
Stress Management/Composure
Education & qualifications
Degree or higher degree in a relevant scientific subject
Master's or PhD in a relevant scientific subject, desirable
Demonstrated computer skills; proven functional knowledge of Microsoft packages (MS Word, Excel, Power Point, Outlook, MS Project, SharePoint)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 i
