Global Development Scientist, Clinical Development and AI

The Global Development Scientist in Clinical Development and AI will provide scientific and clinical input to all aspects of late-stage product development and AI-assisted ways of working. This includes but is not limited to the design, delivery, and interpretation of pivotal clinical trials and of studies that further characterize the overall benefit and risk and value of products in respiratory and immunology therapeutic area (TA) in late-stage development. In this role the scientist will seek input from the appropriate functional experts and will coordinate these activities in support of clinical studies and programs. The Global Development Scientist in Clinical Development and AI will work to ensure that the safety evaluation process for phase II/III trials is seamless and complete, and develop and deploy AI solutions to assist this aim. The objectives of the Global Development Scientist will be set by the Global Clinical Program Lead (GCPL) in agreement with Global Clinical Head (GCH). The role will have a special focus on late-stage clinical trials within the Respiratory TA where the Global Development Scientist will work in close collaboration with the study team physician, sites, and other cross-function stakeholders in Respiratory and the wider AI community with all aspects of scientific input, clinical data quality metrics and safety evaluation. Alongside delivery of the role’s established scientific and clinical responsibilities, the Global Development Scientist will act as a lead for selected AI-enabled use cases—identifying high-value opportunities, translating clinical needs into clear requirements, piloting solutions in live studies, piloting and evaluating workflows, and supporting adoption at scale. A key purpose of the role is to support the deployment of AI-assisted methods that maintain/enhance quality whilst accelerating the design, conduct, data review and interpretation; ensuring the retention of accountable human scientific and clinical judgement and analysis of clinical trials. Always ensuring that the novel AI solutions deployed follow appropriate governance processes and maintain the standards of Good Clinical Practice (GCP). All of this with the ultimate goal of helping to bring new treatments to patients. The role will connect clinical domain expertise with AI capabilities. It will help establish reusable approaches rather than isolated pilots, with success assessed through evidence of adoption and measurable improvements in clinical development outcomes, quality, efficiency or cycle time. You will be expected to collaborate effectively with colleagues in late-stage Respiratory groups, and to build productive connections. You will combine strong scientific judgement with curiosity about emerging AI methods, communicate benefits and limitations clearly, and support colleagues to use approved tools confidently and responsibly. You will present scientific and AI-enabled insights to multidisciplinary teams and key stakeholders and contribute as a member of a diverse, motivated team spanning multiple divisions of Biopharmaceuticals R&D. Typical Accountabilities Provide scientific leadership in the innovative design, execution and interpretation of clinical trials in one or more development programs. Effectively collaborate with colleagues in other functions including Patient Safety, Regulatory Affairs, Clinical Operations, and early development groups. Be involved primarily in late stage (PhIIb and Phase III) clinical programs and to collaborate with clinical colleagues supporting early-stage programs as well as medical affairs colleagues. Provide expert scientific input into the preparation of regulatory documents and interactions with regulatory authorities. Provide expert scientific review, analysis, and interpretation of data from ongoing studies and in the literature. Lead development of quality metrics and data review plan for assigned studies. Identify and prioritise clinical development activities where AI assistance can add meaningful value, define the clinical problem and intended outcome, and agree fit-for-purpose success measures with study and functional partners, including stakeholder alignment, workflow integration, user feedback, training, adoption monitoring and transition from pilot to sustained use Support and contribute to medical monitoring of trials. Lead and participate in activities that ensure quality, consistency and integration of clinical study related deliverables and ensure safety evaluation process within the clinical team. Provide clinical leadership for the testing and validation of AI-assisted outputs, ensuring appropriate human review, traceability, data quality, privacy, security and compliance with applicable quality and regulatory expectations, embedding fit-for-purpose methods into study and programme workflows Ensure scientific input to TA standards. Provide scientific evidence to support strategic decision making for R&D, marketing, clinical, and business development departments. Present protocol and scientific results to multidisciplinary teams and key stakeholders Develop and review protocols, informed consent, investigator’s brochure and other clinical development documents. Organize and analyse data from clinical research to build new hypothesis. Support upskilling in AI-assisted ways of working and contribute to the development of AI capability across Respiratory Clinical Development and engage with AI user networks and relevant cross-functional initiatives to share learning, promote reuse and scale effective AI-assisted practices. Education, Qualifications, Skills, and Experience Relevant university degree with extensive experience from clinical development. </u