Medical Director, Clinical Development Hepatology

Medical Director, Clinical Development 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.

We are seeking a Medical Director, Clinical Development Hepatology for a clinical program in hepatology. The Medical Director, Clinical Development will support the Clinical Development Lead (CDL) and clinical team to plan and execute a clinical program, consisting of late-stage studies in liver disease, with an opportunity to support multiple indications as part of this program's life cycle management plans. You will work as part of a cross-functional team to deliver on a high-priority program, while also contributing to a dynamic and collaborative clinical research community. This role will provide you the opportunity to lead key activities to progress your career.

About RIIRU:

The Respiratory, Immunology and Inflammation Research Unit (RIIRU) was formed in 2024 to identify and advance novel molecular targets with genetic associations to disease based on the foundational observation that targets with human genetic evidence supporting their causal role in the intended indication improves clinical success by two-fold. The remit of RIIRU is to identify novel targets based on human genetics, develop assets for clinical studies, and perform trials through to submission for approvals. This goal is enabled through strategic external (e.g., Flagship Pioneering, Vesalius, Muna Therapeutics and others) and GSK-internal partnerships (Research Technologies).

This career opportunity requires an on-site office presence (minimum of two days a week) at one of GSK's US (PA or MA) or UK (Stevenage or London HQ) sites.

Key Responsibilities:

• Supporting the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for asset(s) in development
• Ensuring alignment with and support of project strategic plans, regulatory requirements, and commercial goals, optimizing clinical study design aligned with IEP and CDP
• Generating the data and evidence required to determine a medicine's potential efficacy, safety profile, key areas of product differentiation, and value to patients.
• Providing effective support and oversight of evidence generation activities to assure patient safety and study delivery.
• Enabling robust protocol design, including selection of clinical endpoints, patient populations, and participant monitoring strategy
• Working with Clinical Operations and Biostatics to deliver clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP
• Active medical monitoring activities and medical data review of ongoing studies, including:
• Lead, coordinate activities and present at IDMCs, adjudication committees, ongoing routine safety review
• Interpretation and presentation of clinical data for clinical study reports and publications
• Oversee and train study team on protocol-related activities in collaboration with matrix study team members
• Developing and maintaining relationships with program counterparts, including Commercial, Research, Regulatory, Clinical Operations, and Statistics
• Interfacing and influencing a diverse range of scientific external experts (e.g., regulators, payors, CROs, consultants, investigators) in order to deliver clinical programs, align to business strategy, and address patient needs.
• Gathering and supporting the integration of inputs from across disciplines (scientific, clinical, commercial, regulatory) to contribute to clinical components of the Medicine Profile
• Contributing to regulatory interactions including briefing documents, presentations, addressing questions and responses
• Serving as a clinical representative for senior management and senior level matrix teams, both internally and externally for an asset in development
• Contributing to the implementation and embedding of strategic initiatives and various organizational initiatives in RIIRU APU
• Supporting technical and leadership development of RIIRU APU staff via mentoring and coaching for matrix team members
• Support enterprise efforts to streamline and grow efficiencies for the business unit

Basic Qualifications:

• Medical degree
• Clinical medical specialty training with board qualification/registration in Internal Medicine or Primary Care / Family Medicine.
• Completion of a full clinical residency program leading to board qualification or certification.
• Experience in clinical drug development, with understanding of clinical trial execution from concept to publication.
• Direct experience with in?stream medical oversight activities during trial conduct.
• Knowledge of ICH guidelines, FDA requirements, and global regulatory expectations.
• Understanding of clinical research methodology and biostatistical principles to support innovative and efficient clinical trial design and data?driven decision rules.

Preferred Qualifications:

• Medical degree plus completion of advanced clinical specialty training with board qualification/registration in Hepatology (or equivalent higher specialty training).
• Familiarity or experience in MASH or ALD drug development, disease biology, therapeutic targets, and current/future treatment landscape.
• Clinical research experience in hepatology, including clinical development planning and interventional study design.
• Experience with site?facing interactions and/or activities supporting medical affairs, patient advocacy groups, or external organizations.
• Demonstrated ability to lead line or matrix teams, with a strong reputation for inspiring and motivating high performance.
• Experience engaging with regulators, payors, and prescribers in relevant markets.
• Experience integrating genetic data to inform clinical protocols.
• Proven ability to apply statistical and data visualization methods to interpret complex information, draw accurate conclusions, and support decision?making.
• Experience using new digital tools and learning technologies to drive innovation.