Medical Director, Clinical Development, Hepatology in London

The Medical Director, Clinical Development, Hepatology is sought to provide clinical and scientific insights to potential new, established and emerging assets in clinical development with a strong focus on liver diseases. You will work within project teams to plan, execute, and deliver clinical development activities up to and including registrational studies. You will report to the Clinical Development Lead. This role is pivotal in driving GSK's mission to deliver transformative medicines to patients, ensuring clinical excellence, regulatory compliance, and operational efficiency.

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 and GSK-internal partnerships.

Location Requirement: This career opportunity requires an on-site office presence (minimum of two days a week) at one of GSK's US or UK sites.

Responsibilities:

• Contribute to project team discussions on indication planning and incorporate input from across disciplines to support vital deliverables including the Target Product Profile (TPP), clinical development plan (CDP), study protocols, and integrated evidence strategy (IES) and planning.
• Provide effective support to the development and execution of the IES, including oversight of R&D evidence generation activities to ensure patient safety and study delivery.
• Design and execute clinical development plans across advanced stages of development, reflecting internal and external stakeholder input.
• Contribute to ambitious clinical development timelines by overseeing development of clinical study protocols, amendments, investigator brochures, clinical study reports etc.
• Input to, and may lead, 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.
• Act as clinical lead for a clinical study, taking a key role on the Study Leadership Team (SLT) and serve as clinical point of contact for a clinical study on the Clinical Matrix Team (CMT).
• Make significant contributions to global regulatory submissions/files.
• Evaluate specific business development activities, including due diligence and contributes to the implementation and embedding of strategic/organizational initiatives in Clinical Development.
• Stay abreast of advancements in therapeutic area research, clinical trial methodologies, competitive environment, and regulatory space.

Additional Responsibilities:

• Demonstrate flexibility and adaptability in changing environments.
• Demonstrate enterprise mindset with effective collaboration across the matrix.
• Embrace challenge as an opportunity, proactively generating ideas for innovative improvement.
• Manage conflicts effectively and independently.
• Analyze, interpret and critically evaluate data, information and digital content.
• Consistently achieve desired outcomes through strong influencing skills.

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 working in the pharmaceutical industry in clinical drug development.
• 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.

Preferred Qualifications:

• Medical degree plus completion of advanced clinical specialty training with board qualification/registration in Hepatology.
• Familiarity or experience in MASH or ALD drug development.
• Clinical research experience in hepatology.
• Experience with site-facing interactions and/or activities supporting medical affairs.
• Demonstrated ability to lead line or matrix teams.
• 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.
• Experience using new digital tools and learning technologies to drive innovation.

Compensation and Benefits: If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $222,750 to $371,250. If you are based in another US location, the annual base salary range is $202,500 to $337,500. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program. Available benefits include health care and other insurance benefits, retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

Equal Opportunity Employer: GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.