Job overview
Are you a pharmacist with clinical trials experience? Are you passionate about advancing clinical research and want to play an expert role in the development of new therapies? Join our expert CTIMPs team at UCL and help shape the future of clinical trials.
We’re looking for a highly motivated specialist pharmacist to take on a key regulatory role in the delivery of UCL-sponsored Clinical Trials of Investigational Medicinal Products (CTIMPs). In this dynamic and collaborative position, you will work closely with specialist trial teams, regulatory bodies, and industry partners to ensure our trials are setup to the highest standards of compliance and innovation.
As the regulatory pharmaceutical expert, you will support senior members of the team on all aspects of IMP sourcing, manufacturing oversight, and supply chain management, supporting trials from early concept through to delivery at clinical sites. You will be the primary contact with pharmaceutical companies, Contract Development and Manufacturing Organisations (CDMOs), and other stakeholders providing regulatory strategy for UCL-sponsored studies.
This role is an exciting opportunity to build deep expertise in the regulatory and CMC (Chemistry, Manufacturing and Control) landscape of early-phase clinical trials. You will ensure compliance with UK medicines regulations, including GCP, and GMP, while also providing specialist support for pharmacy-related queries across Phase I–III trials.
Main duties of the job
The post holder will provide expert regulatory and IMP support for UCL-sponsored CTIMPs, with a focus on trials where the sponsor is responsible for IMP supply. You will work with study teams to define IMP supply chains, provide regulatory and sourcing strategy, and determine documentation requirements for CTA submissions based on study phase and complexity. The role includes reviewing and approving GMP documents ( labels), leading on the development and review of quality agreements with pharmaceutical companies and CDMOs.
The post holder will support on complex regulatory queries, particularly for early-phase and first-in-human trials, including cell and gene therapies. They will also act as a key point of contact for stakeholders on pharmaceutical aspects of UCL-sponsored studies and support site set-up through direct engagement with site pharmacies. This includes responding to IMP-related queries and working closely with the Principal Clinical Trials Pharmacist at UCLH. Strong communication, sound regulatory judgment, and the ability to manage complex stakeholder relationships are essential.
Working for our organisation
University College London Hospitals NHS Foundation Trust (UCLH) is one of the most complex NHS trusts in the UK, serving a large and diverse population. We provide academically led acute and specialist services, to people from the local area, from throughout the United Kingdom and overseas. Our vision is to deliver top-quality patient care, excellent education, and world-class research. We provide first-class acute and specialist services across eight sites:
· University College Hospital (incorporating the Elizabeth Garrett Anderson Wing)
· National Hospital for Neurology and Neurosurgery
· Royal National ENT and Eastman Dental Hospitals
· University College Hospital Grafton Way Building
· Royal London Hospital for Integrated Medicine
· University College Hospital Macmillan Cancer Centre
· The Hospital for Tropical Diseases
· University College Hospital at Westmoreland Street
We are dedicated to the diagnosis and treatment of many complex illnesses. UCLH specialises in women’s health and the treatment of cancer, infection, neurological, gastrointestinal and oral disease. It has world class support services including critical care, imaging, nuclear medicine and pathology.
We are committed to sustainability and have pledged to become a carbon net zero health service, embedding sustainable practice throughout UCLH. We have set an ambitious target of net zero for our direct emissions by 2031 and indirect emissions by 2040.