Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease. We are developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs.
It is an exciting time to join Immunocore. Our most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies. The company also recently completed its Initial Public Offering and was listed on the NASDAQ.
The Clinical Supplies Manager 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 Clinical Supplies Manager 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. The role is located in Conshohocken (Pennsylvania, US), Rockville (Maryland, US) or Abingdon, Oxfordshire (UK).
This is a temporary position, anticipated to be 6 months. It may be extended or has the potential to become a regular full time position.
- 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 CSMs 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 reviewing SOPs
- 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
- 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
- Ability to travel. Limited overnight travel is expected with some international and local travel required. Approximately up to 5 % travel.
- Experience in supporting expanded access studies
- Experience in managing externally sponsored research studies using authorized (marketed) or unauthorized (Investigational Medicinal Products, IMP)
- 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
Education & qualifications
- Bachelor's degree or higher degree in a relevant scientific subject
- Demonstrated computer skills; proven functional knowledge of Microsoft packages (MS Word, Excel, Power Point, Outlook, MS Project, SharePoint)
Candidates must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization. F-1 visa holders with Optional Practical Training (OPT) who will require H-1B status, TNs or current H-1B visa holders will not be considered. H1-B and green card sponsorship is not available for this position.