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.
About you
To be successful in this role, we are looking for candidates to have the following skills and experience:
Essential criteria
1. Degree (or equivalent) in a relevant health related subject/expertise (e.g., Medical, Scientific, Nursing, Pharmacy) and a post graduate qualification with a research methodology element
2. Substantial Experience of working in research or clinical trials, with an understanding of GCP guidelines, including in international multi-site trials.
3. Experience of line managing staff, including clinical research staff (e.g. trial coordinators, monitors), performing objective-setting, performance review and development.
4. Demonstrable experience of leading contract and governance negotiations with clinical sites, commercial partners and/or regulatory bodies on behalf of a research programme or sponsor organisation.
5. Demonstrable experience of leading regulatory strategy and submissions across multi-country clinical research programmes, including direct interaction with regulatory authorities (e.g. MHRA, EMA, FDA or international equivalents) as a primary point of contact.
6. Proven ability to assess and manage risks in clinical trials, including the development and implementation of appropriate mitigation strategies
7. Knowledge of project management methodologies, with the ability to apply these in practice to support effective trial delivery
8. Strong IT and data management skills, including experience of clinical trial management systems (CTMS), electronic data capture (EDC) platforms, and Microsoft Office Suite and experience of establishing and owning a Quality Management System, including authorship of programme- or organisation-level SOPs, and oversight of training and compliance frameworks.
Desirable criteria
1. Formal qualification in clinical trials or clinical research (or working towards one)
2. Project management certification (e.g., PRINCE2, PMP) and/ or Certification in clinical research (e.g., ACRP, SOCRA, or equivalent).
3. Experience in the field of study of the trials (pregnancy studies, digital and remote trials, with an AI component)
4. Track record of contribution to regulatory policy, guidance or thought leadership relevant to programmes such as EMBRACE (healthcare AI, digital health or international clinical research).
5. Able and willing to travel internationally as required.
Downloading a copy of our Job Description
Full details of the role and the skills, knowledge and experience required can be found in the Job Description document, provided at the bottom of the page. This document will provide information of what criteria will be assessed at each stage of the recruitment process.
Further Information
At King’s, we believe that the diversity of our community and a culture that is welcoming, open, inclusive and collaborative, are great strengths of the university.
The Equality Act of 2010 protects the rights of our students and staff and provides a framework to fulfil our duties to eliminate unlawful discrimination, harassment and victimisation and in addition, to advance equality of opportunity and foster good relations between those who share a protected characteristic and those who do not. At times, this will include balancing rights and beliefs that can feel in tension.
We are committed to free speech and to academic freedom, believing that our foundational purpose as a university, is to create spaces where a wide range of ideas, including ideas that are controversial, can be discussed and debated, and where members of our community can express lawful views without fear of intimidation, harassment or discrimination.
When engaging in the robust exchange of ideas, we ask that our community is mindful of our Dignity at King’s guidance.
We ask all candidates to submit a copy of their CV, and a supporting statement, detailing how they meet the essential criteria listed in the person specification section of the job description. If we receive a strong field of candidates, we may use the desirable criteria to choose our final shortlist, so please include your evidence against these where possible.
We reserve the right to close adverts early due to the volume of applications we receive. While the closing date may change, all adverts will close at 23:59 to allow sufficient time for applications to be submitted on that day.
We encourage you to apply at the earliest opportunity to avoid disappointment as once we have closed a vacancy you will be unable to su