Clinical Development Medical Director- Hepatology

Clinical Development Medical Director - Hepatology

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success.

We’re uniting science, technology, and talent to get ahead of disease together.

• Drive development of clinical plans and study designs and ensure alignment with translational plans and project strategies to ensure quality execution of the clinical development plan. 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 the 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 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.

• 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 trial methodologies, competitive environment and regulatory space to maintain GSK’s competitive edge. Identifies and highlights transformational opportunity where projects can offer highly significant benefit to patients in ways not…