Clinical Development Lead

An exciting opportunity has arisen for an experienced Clinical Development Lead to join a highly ambitious, well-funded TechBio company operating at the intersection of clinical development, advanced therapeutics and artificial intelligence.

This is a senior, highly empowered role for someone who wants to shape clinical strategy and take ownership across the full development lifecycle, from late-stage clinical development through to regulatory approval and market readiness.

You'll have the opportunity to influence how programmes are designed and delivered, build robust clinical and quality systems, and explore how AI and emerging technologies can improve the way clinical trials are planned, executed and monitored.

Key responsibilities

• Clinical strategy and programme leadership: Develop and deliver integrated clinical development plans aligned with scientific objectives, regulatory requirements and commercial priorities.
• Clinical trial design: Lead the design of Phase II/III and pivotal studies, including endpoint selection, statistical considerations, patient populations and comparator strategies.
• Regulatory strategy: Oversee clinical and regulatory interactions, including IND/CTA submissions, scientific advice and responses to regulatory agency questions.
• Trial execution: Provide oversight of CROs, vendors and study teams to ensure trials are delivered to the required standards of quality, timelines and budget.
• Quality management: Establish and develop clinical quality management systems, including SOPs, quality processes, inspection readiness and audit preparation.
• Patient safety and data integrity: Provide clinical oversight of trial data, safety monitoring, risk management and clinical study reporting.
• Evidence generation and market readiness: Shape evidence strategies that support regulatory approval, health technology assessment, reimbursement and future commercialisation.
• Innovation and AI: Evaluate and implement AI-enabled tools and innovative clinical methodologies to improve trial design, operational efficiency, data quality and decision-making.
• Stakeholder engagement: Build effective relationships with investigators, scientific experts, regulatory authorities, development partners and internal leadership teams.
• Programme and financial oversight: Contribute to clinical budgets, programme planning, risk mitigation and clear reporting of progress against key milestones.

What you'll need

• 10+ years' experience in clinical development within biotech, pharma, medical devices or a CRO environment.
• A strong track record of leading Phase II/III or pivotal clinical development programmes, ideally through to late-stage development.
• A degree in life sciences, pharmacy, medicine or a related discipline; an advanced degree or PhD would be advantageous.
• Experience in gene therapy, advanced therapeutics or complex clinical development programmes.
• Strong knowledge of clinical trial design, protocol development, endpoint selection and regulatory requirements.
• Direct experience working with regulatory authorities and preparing or contributing to IND/CTA submissions and scientific advice.
• Experience overseeing CROs, vendors, clinical operations, trial budgets and delivery timelines.
• A solid understanding of GCP, clinical quality systems, SOP development, audits and inspection readiness. Experience establishing a QMS would be a significant advantage.
• An understanding of clinical evidence generation beyond regulatory approval, including reimbursement, HTA and commercial considerations.
• An entrepreneurial mindset, with the confidence to challenge established approaches, make decisions and work effectively in a fast-moving, evolving environment.

Experience in neurology, psychiatry, gene therapy or other advanced therapies would be particularly relevant. Exposure to AI-enabled clinical development or innovative clinical trial methodologies would also be beneficial.