Specialist, Clinical Supply Chain in Oxford

Job Title

Specialist, Clinical Supply Chain

Company

Immunocore

Location

Gaithersburg, MD; Radnor, PA; Oxford, UK

Department

Clinical Supply Chain

Key Responsibilities

The Specialist, Clinical Supply Chain role will maintain drug manufacturing and clinical supply chain record keeping in either the Trial Master File or sponsor files in accordance with regulatory expectations. It helps to ensure effective management of drug manufacturing and the supply chain, ensuring seamless provision of drug and ancillary supplies across the clinical portfolio. The Specialist will work closely with internal clinical supply chains, clinical operations, regulatory and manufacturing colleagues to assist in the delivery of clinical supplies in line with related regulatory requirements and internal quality processes.

• Continuously and proactively gather and file clinical supplies related paperwork into either the Trial Master File or sponsor files, ensuring records are inspection ready and compliant with regulations.
• Collaborate with Clinical Supplies Managers in setting up supply chain strategies for clinical studies, resolving issues, sharing best practice, and continually developing competence.
• Design and implement labelling, packaging and supply strategies that meet study design, site, and regulatory requirements while maximizing efficiency.
• Contribute to clinical supply agreement documents, documenting the agreed supply option and detailing the design, setup and operation for responsible studies.
• Manage labelling, packaging and distribution activities, including review and approval of labelling/packaging records and distribution plans.
• Help ensure seamless provision of drug and ancillary supplies by carrying out activities such as:
  • Management of drug temperature excursions during shipment and storage.
  • Drug usage forecasting.
  • 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.
• Assist with activities to help monitor individual study budgets including recording in invoice trackers.
• Support preparing, reviewing, and formatting support documents for clinical trials, including pharmacy handling instructions, pharmacy manual, distribution project specifications, etc.
• Contribute to and review SOPs related to Clinical Supplies and Manufacturing required for the Quality Management system.
• When required, contribute to and review documents for submissions to regulators or ethics committees.
• 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.
• Provide pharmacy training to clinical trial personnel as necessary, which may involve traveling nationally and internationally for face-to-face training.
• Initiate Quality Events where appropriate and support investigation and root cause analysis, including execution of associated CAPAs.

Experience & Knowledge

Essential

• Worked within pharmaceutical quality systems, with a sound understanding of principles of “good practice”.
• Worked within the drug development industry.
• Worked collaboratively with other internal teams.
• Worked to foster support and influenced all study stakeholders throughout the life of a project.
• Worked to meet deadlines.
• Worked to an exceptional standard regarding organisational and computer skills (Word, Excel, Powerpoint, Outlook).

Desirable

• Worked in early phase clinical trials.
• Knowledge and experience in Oncology therapeutic discipline.
• Proven track record of successfully contributing to the running of clinical study projects in a pharmaceutical/biotech business environment.
• Worked in GMP or clinical supplies.
• Knowledge of the Industry/Clinical trial process and drug development.
• Knowledge of ICH GCP.
• Knowledge of GDP.
• Knowledge of the Clinical Trial Directive and global regulatory environment regarding investigational products.

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, PowerPoint, 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 commercialise 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.

At Immunocore, we recognise 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, colour, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.