Clinical Development Medical Director- Hepatology

Medical Director Clinical Development
- Hepatology

GSK is seeking an experienced Medical Director for the role of Medical Director Clinical Development
- Hepatology within GSK's Respiratory, Immunology & Inflammation Research Unit. If appointed to this role you will have key responsibility for the identification of next generation targets for liver disease and the progression of assets directed towards them into the clinic to demonstrate proof of concept. To do this you will provide medical and scientific expertise and leadership to clinical and translational studies at, and above, asset-level;

contribute to assessment of the therapeutic potential of novel mechanisms and targets, collaborate in the design of target validation programs, identify and drive life-cycle expansion and innovative clinical development opportunities. You will work cross-functionally to develop and execute clinical development plans (CDPs) and contribute to above-project development of foundational and real-world data, and translational and biomarker capabilities, within a department that prioritizes understanding mechanism and unmet need alongside innovative clinical development, helping us deliver differentiated medicines that change the course of disease and improve patients' lives.

• Provide effective support and oversight of R&D evidence generation strategy, plan and activities to ensure patient safety and on-time, in-full study delivery. Contribute to the study team discussions on indication planning and incorporate 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.
• Design clinical development plans, study protocols and associated documents across all phases of development, reflecting internal and external stakeholder input (e.g., patients, evidence generation, regulators, payors, pharmacovigilance).
• Bring clinical expertise to regulatory interactions and documents including briefing documents, presentations, addressing questions and responses for assigned studies and programs.
• Provide medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study, together with Pharmacovigilance Physician.
• Accountable for medical governance across the project to ensure scientific integrity and overall safety of the study subjects across the study.
• 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.

• Accountable for leading the Clinical Matrix Team (CMT) for a program. Serves as a clinical point of contact both internally and externally for an indication of an asset or for a clinical study. Represents the CMT at Early/Medicine Development Teams or clinical study at CMT.
• Actively leads the end-to-end clinical development strategy for an early program and may contribute to later stages.
• Serve as the primary Clinical 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 and with the relevant internal review boards (e.g., Technical Review or Governance) and/or Protocol Review Board.
• Assist with clinical evaluation of business development opportunities
• Stay abreast of advancements in research, clinical trial methodologies, competitive environment and regulatory space in the relevant disease area to maintain GSK's competitive edge.
• Identify and highlights transformational opportunities; where projects can offer highly significant benefit to patients in ways not possible with existing approaches.
• Gather and supports the integration of inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to clinical components of the Medicine Profile (MP).
• Consistently contribute to solving study and overall clinical development challenges.
• Demonstrate ability to influence others at project, departmental and inter-departmental levels, as appropriate

• Embrace challenge as an opportunity for creativity and use new learning and digital tools to create innovative approaches to science and technical solutions.
• Promote an environment for others to generate ideas for improvement and proactively drives innovation, beyond taking advantage of opportunities that arise.

• Consistently achieves desired outcomes through strong influencing skills including understanding others' perspectives, building trust, tailoring communications depending on the audience and using persuasive arguments to gain support.
• Able to consistently…