Manager, Clinical Supply Chain

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.

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.

The 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 position is onsite and can be based out of the following offices:
Conshohocken, PA, US
Rockville, MD, US
Abingdon, UK.

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 labeling, 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, labeling and distribution vendors.
 Manages labeling, packaging and distribution activities including review and approval of labeling/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 and reviews 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 traveling 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.

SUPERVISORY RESPONSIBILITY
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 labeling 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)

A valid passport is required for this role.