Director, IT Business Relationship Management – Clinical and Regulatory

BioSpace; Radnor (Delaware County); On-site; USD 180,000 - 280,000; Full time

Job summary

Immunocore is seeking a Director of IT Business Relationship Management to bridge clinical and regulatory business areas with IT. The leader will own the digital and AI strategy for Clinical Development and Regulatory functions, aligning IT investment with corporate goals and regulatory standards.

The ideal candidate brings hands-on Veeva Vault experience, deep knowledge of GxP/21 CFR Part 11, and the vision to transform systems with AI while driving value across the organization.

Qualifications

• Bachelor's degree in Computer Science, IT or Sciences.
• Proven IT PM experience leading regulated systems.
• Ability to influence senior stakeholders and executives.

Responsibilities

• Define the digital strategy and technology roadmap for Clinical/Regulatory IT.
• Lead planning and delivery of IT projects delivering validated solutions.
• Translate business needs into scalable, compliant technology solutions.

Skills

IT project management

Regulatory IT systems

Stakeholder management

Veeva Vault experience

Data governance

Education

Bachelor's degree in Computer Science, IT or Sciences

Tools

Smartsheet

Veeva Vault Platform

Job description

Vacancy Name

Director, IT Business Relationship Management – Clinical and Regulatory

Vacancy No

VN904

Employment Type

Full Time

Location of role

Radnor, PA

Department

Information Technology

Main Purpose of Role

The Director, IT Business Relationship Management (Business Partner) is a strategic partner and subject matter expert bridging Immunocore's business areas and IT. The role owns the digital and AI strategy for Clinical Development, Regulatory and related functions, aligning IT investment with company objectives and long-term competitive positioning.

The ideal candidate has navigated the full arc of clinical-stage growth, from early-phase trials through Phase 3, NDA submission and commercialization, and brings hands‑on Veeva Vault experience, strong command of validated systems and regulatory requirements, and the vision to reimagine systems and processes with AI. Operating with high autonomy, the Director identifies business needs, builds the case for action and leads requirements and solution definition.

Key Responsibilities

Strategic Leadership & Business Partnering

• Act as primary IT business partner to Clinical Operations, Clinical/Medical Development, Quality, Biometrics, Data Management, Clinical Supplies, Regulatory, Technical Operations and Pharmacovigilance/Safety.
• Define the digital strategy and technology roadmap, balancing near‑term delivery with Phase 1–3 scale and health authority submission readiness.
• Partner with the AI and data analytics leads to prioritise AI‑enabled opportunities and ensure data integrations and analytics meet evolving business needs.
• Challenge conventional approaches to reimagine processes and systems, tracking market, competitive and emerging‑technology trends.
• Advise senior stakeholders and develop robust business cases.

Technology Project & Portfolio Management

• Lead planning and delivery of IT projects with business leads, vendors and partners, delivering validated solutions on time and to high quality.
• Resolve complex, ill‑defined issues across multiple areas, making timely decisions with limited information.
• Lead requirements gathering, process mapping and solution design, translating needs into scalable, architecturally aligned solutions that meet GxP, 21 CFR Part 11 and other regulatory standards.
• Manage scope, milestones, risks, resources, budgets and reporting in line with project methodology standards; benchmark performance to raise portfolio maturity.
• Drive change management, end‑user training and adoption so investments deliver intended value.

Collaboration & Influence

• Influence, negotiate and persuade at executive level on difficult concepts, preserving relationships while driving change.
• Lead high‑profile internal and external meetings, communicating complex technical concepts to senior audiences.
• Mentor, and potentially manage, professional and managerial staff as a best‑practice and quality resource.

Operational Excellence, Governance & Vendors

• Shift IT from a service‑provider model to a strategic partnership delivering measurable business value.
• Govern the project portfolio, prioritising highest‑ROI, strategically aligned initiatives.
• Support control environments and standard processes aligned with GxP, SOX, global IT/data legislation and Immunocore policies, including contract reviews.
• Manage IT partners (Conexus and Veeva Systems) against agreed SLAs, including contracting and quarterly business reviews.
• Keep IT Portfolio/CMDB data accurate (e.g., application owner, RTO/RPO, ROI) and linked to backlog prioritisation.
• Flex across IT functions and support UK and US geographies.

Education, Experience and Knowledge

Essential

• Bachelor's degree in Computer Science, IT or Sciences, plus 10+ years of IT project management experience, ideally in Life Sciences or Pharma on projects with regulatory requirements and controls.
• Proven track record developing and executing IT strategy for complex business functions (e.g., Research, Clinical, Commercial, Supply Chain).
• Demonstrable ability to handle ambiguity, solve undefined problems and make strategic decisions with limited information.
• Expertise influencing and negotiating with senior stakeholders and executives on high‑stakes decisions, including where the role does not directly control resources.
• Strong financial acumen: budget management, forecasting and business cases for large‑scale investments.
• Experience leading teams or projects and directing others in multi‑project, multi‑location environments; mentor and best‑practice resource.
• Solid project and portfolio management experience, including methodology, prioritisation, performance monitoring and portfolio health reporting.
• Strong business acumen in Research/Scientific, Clinical or Commercial functions, with the ability to connect business needs to technical solutions and build relationships across the organization.
• Experience in business and process analysis and eliciting requirements across a wide function and user base; ability to spot the business implications of data system designs.
• Proficiency with project planning/scheduling tools (e.g., Smartsheet).
• Familiarity with IT infrastructure, including virtualization, configuration, cybersecurity and SaaS compliance requirements.
• Experience implementing SaaS applications or developing solutions in Life Sciences or similar organisations.
• Strong written and verbal communication across senior stakeholders; able to work independently and collaboratively in a fast‑paced, deadline‑driven environment.

Desirable

• Advanced degree (MBA, MSc) in Business, Sciences or Computer Science.
• International‑scope experience, ideally with exposure to regulatory environments.
• Knowledge of SOX controls and compliance, ideally having embedded them in an organization.
• Experience delivering projects in Quality environments (GxP, CSV and/or 21 CFR Part 11/GAMP); awareness of ISO 9001, ISO 27001 and quality management processes.
• Understanding of waterfall and agile project management techniques.
• Certifications or training: PMP/project management or comparable; Veeva Vault Platform (eTMF, RIM, Registration, etc.); ABPMP
• Process Architect or BCS ISEB Business Analysis, or comparable.
• Education or training in Clinical Development and Regulatory Affairs; corporate functions such as Finance and HR (including their IT/data requirements); or Manufacturing/Supply Chain.
• Experience with MS Power BI, iPaaS (Integration Platform as a Service) tools and/or data platforms such as Snowflake.
• Statistical and information analysis skills, plus valuation and metrics development knowledge.
• Participation in Business Process Improvement projects.

Other

National and occasional international travel is required, and irregular or out‑of‑hours work may be needed at critical project times. This job description is not exhaustive.

Immunocore Values – STRIDE

Science | Trust | Respect | Integrity | Diversity | Entrepreneurship

Immunocore is an equal opportunity employer committed to an inclusive workplace that welcomes individuals of all backgrounds.

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.