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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in hepatology and clinical development, with a strong focus on protocol development, regulatory compliance, and participant safety. Capable of analyzing clinical data and providing medical oversight throughout the trial process.
Highest-signal resume keywords
Medical Degree (MD)Clinical Development ExperienceHepatology ExpertiseKnowledge of ICH/GCP GuidelinesClinical Trial Protocol Development
ATS Keywords
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Hard Skills
Clinical Trial DesignData AnalysisSafety MonitoringProtocol AuthoringRisk ManagementEfficacy InterpretationRegulatory Document PreparationSignal DetectionEligibility Criteria DevelopmentBiomarker Data Analysis
Soft Skills
CollaborationCoachingCommunicationProblem-SolvingLeadership
Industry Keywords
HepatologyClinical ResearchPharmaceutical DevelopmentBiotechnologyGood Clinical Practice (GCP)International Council for Harmonisation (ICH)Regulatory ComplianceClinical Study ReportsInvestigator's BrochuresInformed Consent Forms
About the role
Key responsibilities & impact- Provide scientific and medical expertise at study level across early- and late-phase hepatology assets
- Lead or co-lead development of Phase 1–4 clinical trial protocols and amendments
- Provide medical input into eligibility criteria, endpoints and safety monitoring plans
- Author or oversee protocols, protocol amendments, Investigator’s Brochures, Informed Consent Forms, Case Report Forms, Clinical Study Reports and regulatory documents
- Serve as medical monitor or co-monitor for assigned hepatology trials
- Oversee participant safety, protocol adherence, data quality, safety data review, signal detection and risk–benefit assessments
- Analyse and interpret efficacy, safety and biomarker data
- Integrate internal and external data to support study- and programme-level decisions
- Prepare clinical and regulatory documents, briefing packages and responses to regulatory queries
- Collaborate with Global Study Management, Development Operations, Biostatistics, Safety, Regulatory and Medical Affairs
- Provide hepatology expertise for operational documents 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 compliance with ICH/GCP, GSK SOPs and applicable laws and regulations
- Identify scientific or operational issues and support mitigation approaches and process improvements
- Contribute to consistent ways of working and best-practice sharing
- Coach less experienced clinical scientists and study physicians informally, without formal line management
Requirements
What you’ll need- Medical degree: MD or equivalent is required
- Clinical training and/or significant experience in hepatology or closely related liver disease disciplines
- Bachelor’s degree in life sciences or related discipline
- Clinical development experience in pharmaceutical/biotechnology or academic clinical research, including global interventional trials
- Strong understanding of clinical development processes
- Knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines and relevant regulatory frameworks
- Knowledge of clinical trial designs, risk management and project management
- Location at GSK HQ London, Stevenage, or Ware R&D; successful Stevenage-based applicant must relocate to Cambridge, UK when the office relocation occurs
Benefits
Comp & perks- Agile working culture and flexibility opportunities
- Equal opportunity employment
- Recruitment process adjustments available upon request