Senior Clinical Development Lead - AI-Driven Advanced Therapies

Barrington James; Greater London; On-site; GBP 150,000 - 190,000; Full time

Job summary

Barrington James is excited to partner with a well-funded TechBio company to appoint an experienced Clinical Development Lead. The role sits at the crossroads of clinical development, advanced therapeutics and artificial intelligence.

This senior position offers ownership across the full development lifecycle, from late-stage development through to regulatory approval and market readiness, with opportunities to shape trial design, build robust quality systems and explore AI-enabled innovations.

Qualifications

• 10+ years in clinical development within biotech, pharma, medical devices or CRO.
• Led Phase II/III or pivotal clinical development programmes to late-stage development.
• Degree in life sciences, pharmacy, medicine or related; advanced degree/PhD advantageous.
• Experience in gene therapy, advanced therapeutics or complex development programmes.
• Strong knowledge of trial design, protocol development, and regulatory requirements.
• Direct experience with regulatory authorities and IND/CTA submissions and scientific advice.
• Experience overseeing CROs, vendors, budgets and delivery timelines.

Responsibilities

• Develop and deliver integrated clinical development plans aligned with scientific objectives, regulatory requirements and commercial priorities.
• Lead the design of Phase II/III and pivotal studies, including endpoint selection and population.
• Oversee clinical and regulatory interactions, including IND/CTA submissions and scientific advice.
• Provide oversight of CROs, vendors and study teams to ensure trials meet quality, timelines and budget.
• Establish and develop clinical quality management systems, SOPs, inspection readiness and audit preparation.
• Provide clinical oversight of trial data, safety monitoring and risk management.
• Shape evidence strategies to support regulatory approval, HTA, reimbursement and future commercialisation.
• Evaluate AI-enabled tools to improve trial design, operational efficiency and data quality.
• Engage investigators, regulatory authorities and development partners to support milestones.
• Contribute to budgets, programme planning and risk mitigation.

Skills

Clinical development

Phase II/III leadership

Regulatory strategy

Trial design

GCP compliance

AI in trials

Stakeholder engagement

Budget management

Education

Life sciences degree

Advanced degree / PhD

Job description

Barrington James is excited to partner with a well-funded TechBio company to appoint an experienced Clinical Development Lead. The role sits at the crossroads of clinical development, advanced therapeutics and artificial intelligence.

This senior position offers ownership across the full development lifecycle, from late-stage development through to regulatory approval and market readiness, with opportunities to shape trial design, build robust quality systems and explore AI-enabled innovations.