Senior Clinical and Regulatory Programme Manager

About us King’s College London is an internationally renowned university delivering exceptional education and world-leading research. We are dedicated to driving positive and sustainable change in society and realising our vision of making the world a better place. We are delighted to announce exciting new opportunities to join our community. EMBRACE is a visionary, multicomponent international research programme, the first of its kind in the world, supported by Inkfish with £35M core funds over six years, starting in April 2025. It is a global study of 60,000 participants, including 20,000 mothers, 20,000 infants and up to 20,000 partners. It brings together world-leading clinician scientists across six distinguished Healthcare organisations, world-leading AI & technology companies, together with premier biotech companies, with the overarching aim to fast-track major scientific breakthroughs, revolutionise maternal and early childhood health through precision-personalised interventions, powered by a groundbreaking symbiosis of cutting-edge AI combined with human support. About the role The EMBRACE Senior Clinical and Regulatory Programme Manager will lead the operational delivery and regulatory oversight of clinical trials within the EMBRACE programme. The post holder will be responsible for establishing, implementing and monitoring high standards of clinical trial conduct across all participating sites, ensuring compliance with international regulatory requirements, Good Clinical Practice (GCP), and relevant quality frameworks. The role will provide leadership across a complex, multi-country research environment, overseeing trial operations, regulatory approvals, and the implementation of data capture systems (e.g. EDC platforms and mobile technologies). The post holder will ensure robust standards for data integrity, governance and privacy, in line with applicable data protection legislation (including GDPR) and institutional policies. Working closely with the Chief Investigator (Professor Josip Car) and the EMBRACE Chief Operating Officer, the post holder will play a key role in ensuring that clinical trials are delivered safely, efficiently and to the highest scientific and ethical standards. The role requires substantial experience in clinical trial management, with demonstrable expertise in regulatory compliance, ideally within an academic or complex multi-partner research setting. As a senior member of the programme leadership team, the post holder will shape the regulatory strategy for EMBRACE and contribute to design, delivery and monitoring across the portfolio of studies. They will lead regulatory submissions and act as the first point of contact for regulatory authorities, lead contracting negotiations with sites, commercial partners and regulatory bodies, and establish the programme’s Quality Management System (QMS), including programme-specific Standard Operating Procedures (SOPs), training and compliance frameworks. The post holder will also provide line management to junior trial coordinators and trial monitors as the programme team expands. This is a full-time post (35 hours per week), and you will be offered a fixed term contract until 31/12/2029. The successful candidate will be required to work onsite at least four days per week and will work across two sites, Guy’s Campus and Denmark Hill.