Medical Director, Clinical Development, Hepatology

We are seeking a Medical Director, Clinical Development Hepatology for a clinical program in hepatology. The Medical Director will support the Clinical Development Lead (CDL) and clinical team to plan and execute late‑stage studies in liver disease, with an opportunity to support multiple indications as part of the program’s life‑cycle management plans. This role will enable you to lead key activities and progress your career.

The Respiratory, Immunology and Inflammation Research Unit (RIIRU) was formed to identify novel targets based on human genetics and develop assets for clinical studies. It collaborates with external and internal partners to advance trials through to approval.

Key Responsibilities

• Support the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for assets in development.
• Ensure alignment with project strategic plans, regulatory requirements, and commercial goals, optimizing clinical study design in line with IEP and CDP.
• Generate data and evidence to determine a medicine’s potential efficacy, safety profile, key differentiators, and value to patients.
• Provide effective support and oversight of evidence generation activities to assure patient safety and study delivery.
• Enable robust protocol design, including selection of clinical endpoints, patient populations, and monitoring strategy.
• Work with Clinical Operations and Biostatistics to deliver clinical development timelines and enable key decision points and Go/No‑Go criteria for the CDP.
• Active medical monitoring and data review of ongoing studies, including leading IDMCs, adjudication committees, routine safety reviews; interpreting and presenting clinical data for study reports and publications; overseeing and training study teams on protocol‑related activities.
• Develop and maintain relationships with program counterparts—Commercial, Research, Regulatory, Clinical Operations, and Statistics.
• Interface and influence external experts such as regulators, payors, CROs, consultants, and investigators to deliver clinical programs, align with business strategy, and address patient needs.
• Gather and support integration of inputs from across disciplines to contribute to clinical components of the Medicine Profile.
• Contribute to regulatory interactions, including briefing documents, presentations, and responses to questions.
• Serve as a clinical representative for senior management and senior level matrix teams, both internally and externally for an asset in development.
• Contribute to implementation and embedding of strategic initiatives and organizational initiatives in RIIRU APU.
• Support technical and leadership development of RIIRU APU staff via mentoring and coaching of 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, 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 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 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.

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. The US salary ranges take into account work location within the US market, candidate skills, experience, education level, and market rate. In addition, this position offers an annual bonus and eligibility to participate in a share‑based long‑term incentive program. Benefits include health care, other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.