Associate Director - Clinical Development (Hepatology)

At GSK we are looking for a capable medical professional to join our Hepatology Clinical Development department.   The Associate Director – Clinical Development provides scientific and medical expertise at the study-level across early-and late-phase hepatology assets.  The role operates within cross-functional global study teams to deliver high-quality, timely data that inform asset and portfolio decisions in hepatology.  The role is a senior contributor focused on: • Medical monitoring and safety oversight of assigned hepatology clinical trials (Phase 1–4).  • Authoring and leading the development of protocols and other key study documents (e.g. Investigator’s Brochure (IB), Informed Consent Form (ICF), & Clinical Study Report (CSRs).  • Supporting the design, conduct and interpretation of studies in alignment with the Clinical Development Plan (CDP).     Key Responsibilities (include..): • Lead or co-lead development of clinical trial protocols and amendments for hepatology assets (Phase 1–4), ensuring scientific robustness, operational feasibility and alignment with CDP aims.  Provide core medical input to eligibility criteria, endpoints and safety monitoring plans for hepatology populations (based on general hepatology clinical practice). • 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.  Ensure scientific accuracy, internal consistency and clarity across study documentation. • Serve as study medical monitor (or co-monitor) for assigned hepatology trials, providing day-to-day medical oversight of participant safety, protocol adherence and data quality.  Participate in safety data review, signal detection and risk–benefit assessments, with timely escalation and documentation of safety-related decisions. • Analyse and interpret emerging clinical data (efficacy, safety and relevant biomarkers) to generate study-level insights in hepatology indications.   Integrate internal and external data (e.g. literature, competitor data) to support robust decision-making at study and programme level. • Lead or support preparation of clinical and regulatory documents (e.g. CSRs, briefing packages, responses to regulatory queries) for hepatology studies.  Ensure alignment with GCP, ICH guidelines and applicable global/local regulatory frameworks. • Act as a member of the Clinical Matrix Team (CMT) and study-level cross-functional teams, collaborating with Global Study Management, Development Operations, Biostatistics, Safety, Regulatory and Medical Affairs.  Provide expert hepatology input into operational documents (e.g. Safety Management Plan, protocol deviation management plan, training materials) and study delivery plans. • Prepare and deliver scientific content for investigator meetings and site communications; respond to medical questions and represent the hepatology programme as a subject-matter expert. • Ensure assigned studies are conducted in accordance with ICH/GCP, GSK SOPs and all applicable laws and regulations, maintaining inspection readiness and robust documentation. • Identify scientific or operational issues at the study level and support development of mitigation approaches and process improvements in hepatology clinical development. • 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 on protocol development, medical monitoring and documentation standards (no formal line management).     Location:   GSK HQ London, Stevenage, or Ware R&D.   Please Note: If the succ