Senior Specialist, Clinical Supply Chain

About the job

Location of role

Gaithersburg, MD

Conshohocken, PA

Oxford, UK

Department: Clinical Supply Chain

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 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:

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 Company: 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.

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