Associate Director – Clinical Development

We are looking for a capable medical professional to join our Hepatology Clinical Development department as an Associate Director – Clinical Development. The role provides scientific and medical expertise at the study-level across early-and late-phase hepatology assets.

Key Responsibilities:

• Lead or co-lead development of clinical trial protocols and amendments for hepatology assets (Phase 1–4)
• Author or oversee authoring of protocols, protocol amendments, Investigator’s Brochures (IBs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), Clinical Study Reports (CSRs) and study-level regulatory documents
• Serve as study medical monitor (or co-monitor) for assigned hepatology trials
• Analyse and interpret emerging clinical data to generate study-level insights in hepatology indications
• Lead or support preparation of clinical and regulatory documents for hepatology studies
• Act as a member of the Clinical Matrix Team (CMT) and study-level cross-functional teams
• Prepare and deliver scientific content for investigator meetings and site communications
• Ensure assigned studies are conducted in accordance with ICH/GCP, GSK SOPs and all applicable laws and regulations
• Identify scientific or operational issues at the study level and support development of mitigation approaches and process improvements
• Contribute to implementation of consistent ways of working and sharing of best practice across Hepatology Clinical Development
• Provide informal coaching and guidance to less experienced clinical scientists and study physicians

Location: GSK HQ London, Stevenage, or Ware R&D. Please note that if the successful applicant is based at Stevenage site, the role will temporarily be based at Stevenage, but the Company plans to relocate its offices to Cambridge, UK.

Qualification: Medical degree (MD or equivalent) is required, with clinical training and/or significant experience in hepatology or closely related liver disease disciplines.