Freelance Contract Hybrid: 3 Days On Site In London or Edinburgh Accountable for the successful delivery of clinical programmes within agreed timelines, budgets, and quality standards Provide strategic input into, and participate in, key interactions with regulatory authorities, HTA bodies, and other stakeholders to support programme delivery Evaluate opportunities and provide recommendations regarding clinical collaborations within rare disease and/or rare oncology, including assessments of scientific viability and development potential Act as programme lead across selected programmes and strategic projects where required 15+ years of relevant experience within clinical development. ~ PhD or MD preferred. ~ Extensive global clinical development experience across pharmaceutical, biotechnology, academic, diagnostics, devices, or related medical technology environment ~ Demonstrated experience in asset selection and programme prioritisation. ~ Strong experience supporting IND/CTA submissions and NDA/MAA/BLA regulatory pathway ~ Experience interacting with national and international regulatory authorities ~ Professional qualifications in clinical research and/or clinical project management are advantageous ~
