Clinical Development Lead

Reporting directly to the Chief Medical Officer, the successful candidate will combine strong scientific and clinical development expertise with the ability to operate effectively in a lean, entrepreneurial and fast-moving environment., * Develop and execute clinical development plans aligned with broader commercial and portfolio strategy.

• Lead and contribute to Phase II and Phase III clinical trial design, including protocol development.
• Provide clinical and scientific input into regulatory submissions and CTA applications, working closely with Regulatory and other cross-functional teams.
• Develop evidence-generation strategies extending beyond the clinical trial programme to support future market access and adoption.
• Work closely with regulators, physicians, external experts and HTA bodies.
• Lead ongoing medical and clinical data review, supporting interpretation of emerging clinical evidence.
• Contribute to launch and evidence-readiness activities for late-stage programmes.
• Support budget development, forecasting and broader financial planning for clinical programmes.
• Work collaboratively across Clinical Operations, Regulatory, Medical, Commercial and other relevant functions.
• Contribute to innovative approaches to clinical development, including the potential application of AI and novel clinical methodologies.

• Extensive experience in clinical development within a biotechnology environment.
• Strong experience across late-stage clinical development, ideally including Phase II and Phase III programmes.
• Experience developing clinical programmes beyond the traditional clinical trial setting, including evidence generation and launch readiness.
• Strong knowledge of clinical trial and protocol design.
• Experience interacting with regulatory authorities, physicians and HTA stakeholders.
• Experience within neurology and/or psychiatry.
• Experience in gene therapy or other advanced therapy modalities.
• Experience within diagnostics, including IVD, companion diagnostics and/or software-based diagnostic tools.
• Scientific qualification such as a PhD, PharmD, MSc or equivalent.
• Experience contributing to regulatory submissions and clinical trial applications.
• Ability to work effectively within a lean, entrepreneurial and rapidly evolving biotech environment.
• Strong cross-functional communication, leadership and stakeholder-management skills., * Experience incorporating AI, digital technologies or novel methodologies into clinical development.
• Exposure to the interface between clinical development, evidence generation, market access and commercial strategy.