Clinical Development Medical Director - Hepatology

GSK is seeking a Clinical Development Medical Director - Hepatology to act as a translational leader within the Early Pipeline Unit (EPU) of the Respiratory, Immunology and Inflammation Research Unit (RIIRU). The successful individual will provide medical and scientific expertise to pre-clinical, clinical and translational studies. They will lead programs or work within project teams to conceptualize, design, plan and execute projects including first-time-in-human trials for new assets, experimental medicine studies and translational data generation.

They will work cross-functionally to develop and execute clinical development plan(s) up to, and including, Proof of mechanism/Proof of concept studies. This is an exciting opportunity to bring new therapies into the clinic with a particular focus on treatments for steatotic liver disease (including MASH and ALD) and chronic Hepatitis

B.

• Drive development of clinical plans and study designs and ensure alignment with translational plans and project strategies to 吉林 ensure quality execution of the clinical development planوجوان Will develop sections of core regulatory documents.
• Generate the data and evidence required to determine a target or medicines’ potential efficacy, safety profile, key areas of product differentiation and route to becoming a medicine with value to patients in the shortest possible timeframe
• Deliver clinical development and study timelines and endpoints, including pharmacology, mechanism and clinical efficacy endpoints, enabling key decision points and Go/No Go criteria for the CDP.
• Seek and maintain relationships with program counterparts in Biology, Translational, Commercial, Research, Regulatory, Clinical Operations, Access, Medical Affairs and Statistics.
• Contribute to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Development

• Designs clinical development plans and study protocols across all phases of development, reflecting internal and external stakeholder input (e.g. patients, evidence generation, regulators, payors, pharmacovigilance)
• Develops clinical study protocols, amendments, investigator brochures and clinical study reports.
• Contributes to the study team discussions on indication planning, incorporates input from across disciplines (scientific, clinical, commercial, regulatory, stats, etc) to contribute to vital deliverables including early Medicine Profile, Target Validation, Translational Plans, Candidate Selection.
• Provides effective support and oversight of R&D evidence generation activities to assure patient safety and study delivery.
• Inputs to regulatory interactions and documents including briefing documents, presentations, addressing questions and responses for assigned studies and programs.
• Provides medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study, together with Pharmacovigilance Physician. Accountability for Medical
• Governance across the project to ensure scientific integrity and overall safety of theාing study subjects across the study.

• Actively leads the end-to-end clinical development strategy for an EPU program and may contribute to later stages. Accountable for leading the CMT on an EPU program. Serves as a clinical point of contact both internally and externally for an indication of an asset indication (i.e. Pre-POC and single indication) or for a clinical study. Represents the clinical matrix team at EDT or clinical study at CташM.
• Collaborate with cross-functional teams, including biology, translational, regulatory affairs, medical affairs, and commercial teams, to ensure cohesive and comprehensive translational and clinical development plans. Act as Clinical Lead at study level.
• nombre de Surname… Serves as the primary clinical interface with the relevant internal RIIRU/GSK review board (ie Technical Review or governance) and/or Protocol Review Board.
• Clinical evaluation of business development opportunities.
• Stays abreast of advancements in hepatology research, clinical…