Clinical Program Lead | Immunology | UK | Hybrid

Clinical Program Lead | Immunology | UK | Hybrid

About the Company

Our client is a global, innovation-driven biotech organisation undergoing rapid expansion across the UK and Europe. With a strong focus on immunology, they are advancing next-generation therapies designed to address severe, complex conditions driven by immune system dysfunction.

Their pipeline represents a shift away from symptomatic management toward disease-modifying approaches, leveraging cutting-edge science to deliver meaningful, lasting improvements in patient outcomes. Backed by strong investment and a growing clinical footprint, the organisation offers a highly dynamic environment with significant scope for impact.

The Opportunity

This is a high-impact leadership role within the Global Clinical Affairs team, offering full ownership of EU clinical programs. You will play a pivotal role in bringing innovative therapies through development, directly contributing to the organisation's growth in the UK and wider European market.

The position offers strong visibility across senior leadership and the opportunity to shape clinical strategy, delivery, and operational excellence within a scaling biotech.

Key Responsibilities

Clinical Program Leadership

• Lead end-to-end EU clinical programs from study design through to reporting and submission readiness
• Define and execute clinical program strategy aligned with global development objectives
• Maintain full oversight of timelines, budgets, quality, and risk management
• Provide regular updates and strategic insights to senior stakeholders
• Drive cross-functional collaboration across Clinical, Regulatory, Medical, and Commercial teams

Study Design & Execution

• Lead protocol development with a focus on Quality by Design principles
• Oversee study conduct to ensure high standards of data integrity, patient safety, and compliance
• Supervise data management processes including data cleaning, validation, and review
• Lead the development of Clinical Study Reports (CSRs) and key clinical deliverables
• Ensure continuous inspection readiness and support regulatory audits and inspections

Site & Vendor Management

• Oversee site feasibility, selection, start-up activities, recruitment, and performance monitoring
• Build and maintain strong relationships with investigators, key opinion leaders, and external experts
• Lead investigator meetings, site engagement initiatives, and training
• Select, manage, and oversee CROs and external vendors, ensuring delivery against scope, timelines, and quality standards

Leadership & Team Development

• Lead, coach, and mentor Clinical Operations team members
• Manage direct reports and support professional development and performance management
• Oversee resource planning and allocation across programs
• Contribute to building scalable clinical capabilities aligned with organisational growth

Innovation & Continuous Improvement

• Drive process improvements and clinical trial innovation initiatives
• Support the integration of digital tools and technologies to enhance operational efficiency
• Contribute to the evolution of clinical strategy within a rapidly expanding biotech environment
• Represent the organisation at external meetings, conferences, and regulatory interactions

Candidate Profile

• Proven experience leading EU clinical programs within biotech or pharma
• Strong working knowledge of ICH GCP and European regulatory requirements
• Demonstrated success delivering complex, multi-country clinical trials
• Experience overseeing data management, analysis, and clinical reporting
• Strong leadership capability with experience managing and developing teams
• Excellent stakeholder management and cross-functional collaboration skills
• Ability to work autonomously in a fast-paced, evolving environment
• Eligible to work in the UK

Why Join

• High visibility role with direct impact on innovative immunology therapies
• Opportunity to contribute to treatments addressing significant unmet medical need
• Play a key role in scaling UK and EU clinical operations within a growing biotech
• Collaborative, science-driven culture with access to leading experts
• Competitive package and flexible hybrid working model

Location & Package

• Surrey, United Kingdom
• Hybrid working model (2-3 days onsite)
• Permanent, full-time position