Clinical Development Medical Director- Hepatology

Job description

For candidates seeking to be located at our Stevenage site, this role will temporarily be based at Stevenage. However, the Company plans to relocate its offices to Cambridge. The location of this role will therefore subsequently change to Cambridge in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029. 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. We are 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. In the Respiratory, Immunology, and Inflammation Research Unit (RIIRU), our enduring purpose is to leverage science to identify novel treatments to address underlying organ dysfunction and disease. We are trailblazing a pipeline of medicines to dramatically improve how we cure and care for patients. We are a diverse team of industry-leading experts who channel our passion for scientific exploration into true value for patients and GSK. We drive the end-to-end R&D journey, fueling early discovery and our mid-stage pipeline while also advancing our late-stage medicines to launch. We are combining field-leading data sets, capabilities and methods with decades of knowledge, to transform our success in how we innovate new medicines. Working model: This role is hybrid. You will be on-site at one of the posted locations at least two days per week. Remote work is available on other days. Position Summary: This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Clinical Development Strategy and Study & Program DesignProvide 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. Clinical LeadershipAccountable 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 Creating Innovative Scientific and Technical SolutionsEmbrace 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. Influencing and Inspiring Others and Managing ConflictConsistently 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 inspire others by setting a positive example, communicating a compelling vision, and creating an environment where team members feel valued and motivated. Manage conflicts effectively and independently, negotiating mutually acceptable solutions. Enterprise Mindset, Strategic Thinking and Navigating AmbiguityDemonstrate enterprise mindset with effective collaboration across the matrix, able to integrate cross-functional knowledge into decision-making processes and balance team objectives with the wider business goals. Analyses, interprets and critically evaluates data, information and digital content to interpret complex information, anticipate obstacles and identify potential solutions. Demonstrate flexibility and adaptability in changing environments, able to analyze incomplete information, identify potential risks and implications, and make informed decisions. Why You?Basic Qualifications:We are looking for profession