Senior Clinical Research Physician
il y a 23 jours
Cambridge
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: eligibility review, safety review, dose decisions, and management of adverse events., • Chair/participate in safety review committees and dose‑escalation meetings for early‑phase studies., • Ensure robust medical documentation, source data verification, and high‑quality clinical reporting from the unit, • Represent the CUC internally and externally as PI, including liaison with non‑GSK co‑development partners (e.g. NHS Trusts, university collaborators, research facilities) as required., • Ensure standards are maintained to enable the delivery of consistent high quality and safe clinical trial conduct, at the CUC, through relevant audit and quality improvement and governance activities, • Ensures compliance with acceptable medical standards and the requirements of the protocol, standard operating procedures, ICH GCP, Research Ethics Committees (RECs), regulatory authorities and other applicable guidelines and regulations., • Accountable for responding to questions from RECs, and regulatory authorities as required., • Lead inspection readiness and response activities (MHRA, EMA, FDA, other authorities) for the unit., • Sponsor continuous improvement initiatives in quality systems, SOPs, and risk management processes across the unit., • Ensure alignment with GSK internal policies, medical governance, and R&D quality frameworks., • Provide line leadership and coaching to the team of clinical research physicians, • Provide senior medical input into training of clinical staff at the CUC and support delivery and maintenance of appropriate in‑house clinical skills in the context of clinical trials., • Aid the development of multidisciplinary staff through teaching, training and supervision, acting as a role model for good clinical and research practice., • Support recruitment, retention, and development of high‑calibre physician‑scientist talent for the unit., • Foster an inclusive, learning‑oriented culture that encourages scientific curiosity, ethical conduct, and operational excellence., • Represent GSK and Clinical Unit Cambridge in external scientific and clinical forums (congresses, advisory boards, collaborations)., • Contribute to peer‑reviewed publications and scientific communications from unit studies., • Strengthen the unit’s reputation as a leading experimental medicine centre, attracting high‑quality collaborations and participants., • Medical degree with full GMC registration and licence., • UK‑trained doctors must have completed early Specialty or GP training, with acute medicine experience., • Non‑UK‑trained doctors must demonstrate clinical practice and get GMC registration., • Industry or academic experience in early clinical development / experimental medicine, including acting as PI or sub‑investigator on interventional trials, aligned with MHRA accreditation requirements., • Experience in clinical pharmacology in early phase I/II studies, in a clinical or academic setting., • Experience with biomarker strategy, PK/PD, and mechanism‑of‑action‑driven development., • Experience managing study teams focused on quality, on‑time and on‑budget delivery of clinical trials., • Experience working with central teams on FTIH and early clinical development/translational medicine., • A relevant post‑graduate qualification in clinical pharmacology is desirable., • Commitment to train toward and/or the Advanced Life Support Provider (as a minimum) qualification of the UK Resuscitation Council (UK)., • Strong verbal and written communication skills, ability to present and think critically along with a strong academic background., • Excellent interpersonal skills and energy to operate in a complex organisation environment, positive mindset and willingness to learn and develop in the role., • Ability to maintain and develop relationships and networks with different communities., • Familiarity with advanced methodologies (adaptive designs, modelling/simulation, digital health tools, imaging, etc.) is an advantage. Clinical Development, Drug Regulatory Affairs, Evidence Based Decision Making, Good Clinical Practice (GCP), Influencing Without Authority, Learning Agility, People Management, Project Management, Scientific Presentations, Strategic Thinking Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. 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In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at #J-18808-Ljbffr
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