Senior Clinical Research Physician

Senior Clinical Research Physician

Location: UK
- Cambridgeshire
- Addenbrookes

Remote type: On-Site

Time type: Full time

The Clinical Unit Cambridge (CUC) is GSK’s MHRA-accredited early-phase clinical and translational medicine centre, combining Phase I clinical trial delivery, advanced translational science, biomarker discovery, single-cell and spatial omics capabilities, and technology-enabled operations to generate high-quality human data. Embedded within the Cambridge biomedical ecosystem and closely connected to academia, healthcare and industry partners, CUC accelerates FTIH and early clinical studies, de-risks decision-making, and improves the probability of technical and regulatory success across GSK’s early-stage pipeline.

This role will provide clinical leadership and management of a team of clinical research physicians as Principal Investigator (PI) for early-phase and experimental medicine studies at Clinical Unit Cambridge to deliver high-quality, ethically conducted trials that drive mechanistic insight and decision-making for GSK’s portfolio. You will integrate clinical and scientific expertise, working closely within the Early Pipeline Unit and central GSK teams on early clinical development and translational medicine, and are expected to act as Principal Investigator (PI) on clinical pharmacology, experimental medicine and First-Time-In-Human (FTIH) studies.

• Work closely with central GSK teams to provide CUC medical and scientific expertise into the design, conduct, and interpretation of early-phase and experimental medicine studies including FIH, PoM, PoC, and mechanistic studies.
• Act as co-Investigator or Principal Investigator on clinical pharmacology studies, experimental medicine studies and FTIH trials, in line with level of experience and MHRA accreditation requirements.
• Act as senior clinical/scientific authority on protocol development, risk–benefit assessment, and data interpretation for unit studies.
• Be accountable for authoring (where required), reviewing and approving the Informed Consent Form (ICF) and relevant Research Ethics Committee (REC) submission documentation, and responding to REC and regulatory authority questions.
• Lead and perform protocol-related activities including participant recruitment support, obtaining informed consent, medical screening, ongoing monitoring, post-study clinical examinations, and review/interpretation of vital signs, ECG, spirometry, Holter and laboratory test results.
• Perform and/or oversee study-specific diagnostic/therapeutic procedures (e.g. venepuncture, cannulation, suction blisters, punch biopsies, ECGs) and assist with their processing.
• Provide flexible support for clinical activities on an as-needed basis, including oversight when procedures are undertaken by nursing staff and Physician Associates.
• Dose and/or provide oversight of dosing of investigational medicinal products (IMPs) and non-IMPs via oral, intravenous, subcutaneous and other routes, ensuring safe and accurate administration.
• Provide complete medical cover (in conjunction with other unit physicians) for recruitment, study conduct and follow-up, including coordination and provision of medical cover outside normal working hours as defined by protocols and senior medical leadership, and participate in out-of-hours on-call rotas.
• Drive innovation in trial methodologies (e.g., adaptive designs, integrated PK/PD, digital endpoints, imaging) aligned with GSK R&D strategy.

• Hold primary responsibility for medical safety and governance decisions on assigned studies, escalating as appropriate
• Serve as named PI for allocated clinical studies, accountable for participant safety, data integrity, and regulatory/GCP compliance at the unit.
• Develop strategies to anticipate and expertly manage medical safety issues, including clinical emergencies in the unit and during study participation.
• Lead the management of adverse events and medical emergencies, including clinical decision-making, intervention, documentation and communication.
• Provide day-to-day medical oversight for study conduct:…