Clinical Development Director - Hepatology

Clinical Development Director - Hepatology provides clinical and scientific insights and leadership to clinical and translational studies or programs within the Early Pipeline Unit (EPU) of the Respiratory, Immunology and Inflammation Research Unit (RIIRU). The appointed individual will work within project teams to plan, execute, and deliver activities including hepatology translational and clinical development strategies and clinical studies, particularly within the area of steatotic liver disease (SLD).

You will work cross-functionally to develop and execute clinical development plan(s) up to, and including, Proof of mechanism/Proof of concept studies.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

• Support alignment of translational and clinical plans and study designs with project strategies to ensure quality execution of IEP and CDP. 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
• Define and deliver the clinical pillars of the translational table. 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

• Provides effective support and oversight of R&D evidence generation activities to assure patient safety and study delivery.
• 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.
• 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, clinical study reports etc.
• 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. If physician, accountability for Medical Governance across the project to ensure scientific integrity and overall safety of the study subjects across the study.

• 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 CMT.
• 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.
• Actively leads the end-to-end clinical development strategy for an EPU program and may contribute to later stages. Serve as the primary point of contact for an investigational agent (early development) or clinical study for internal and external stakeholders, including regulatory agencies, key opinion leaders, and clinical investigators.
• Serves as the primary clinical interface with the relevant internal RIIRU/GSK review board (i.e. Technical Review or governance) and/or…