Medical Director, Clinical Development – Hepatology

GSK

Medical Director advancing GSK’s hepatology medicines through clinical development. Leading trials, safety oversight, regulatory submissions, and cross-functional project teams.

Posted 9/4/2026full-timeWaltham • Massachusetts, Pennsylvania • 🇺🇸 United StatesLead💰 $222,750 - $371,250 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical development planning and execution, particularly in liver diseases, with a strong understanding of regulatory requirements and clinical trial methodologies. Capable of leading cross-functional teams and providing medical oversight while integrating innovative methodologies and digital tools.

Highest-signal resume keywords

Medical DegreeClinical Drug Development ExperienceRegulatory Submissions (IND, NDA, BLA, MAA)Clinical Research MethodologyMedical Oversight Activities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Development PlanningClinical Trial ExecutionBiostatistical PrinciplesClinical Study ProtocolsRegulatory InteractionsMedical MonitoringEvidence Generation ActivitiesData Visualization MethodsInterventional Study DesignHepatology Expertise

Soft Skills

CollaborationLeadershipCommunicationStrategic ThinkingProblem-Solving

Tools & Technologies

Digital ToolsLearning Technologies

Certifications & Qualifications

Board Qualification in Internal MedicineBoard Qualification in Primary Care / Family MedicineBoard Qualification in Hepatology (Preferred)

Industry Keywords

ICH GuidelinesFDA RequirementsClinical ResearchPharmaceutical IndustryPatient Advocacy GroupsRegulatory ExpectationsMASH Drug DevelopmentALD Drug DevelopmentTherapeutic TargetsTreatment Landscape

About the role

Key responsibilities & impact

Provide clinical and scientific insights to potential new, established, and emerging assets in clinical development, focusing on liver diseases
Work within project teams to plan, execute, and deliver clinical development activities through registrational studies
Contribute to indication planning and cross-functional project team discussions
Support deliverables including the Target Product Profile, clinical development plan, study protocols, and integrated evidence strategy
Support development and execution of the integrated evidence strategy and oversee R&D evidence generation activities
Design and execute clinical development plans across advanced development stages
Oversee clinical study protocols, amendments, investigator brochures, and clinical study reports
Input to or lead regulatory interactions and documents, including briefing documents, presentations, and responses
Provide medical monitoring and oversight of participant safety with the Pharmacovigilance Physician
Lead Medical Governance across projects when acting as physician
Act as clinical lead for a clinical study and participate in the Study Leadership Team
Serve as clinical point of contact on the Clinical Matrix Team and across internal and external stakeholders
Contribute to global regulatory submissions including IND, NDA, BLA, and MAA
Evaluate business development activities including due diligence
Contribute to strategic and organizational initiatives in Clinical Development
Adopt innovative methodologies, digital tools, and technology
Monitor advances in therapeutic research, clinical trial methodologies, competition, and regulatory developments

Requirements

What you’ll need

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
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
Advanced clinical specialty training with board qualification/registration in Hepatology or equivalent higher specialty training (preferred)
Familiarity or experience in MASH or ALD drug development, disease biology, therapeutic targets, and treatment landscape (preferred)
Clinical research experience in hepatology, including clinical development planning and interventional study design (preferred)
Experience with site-facing interactions and/or activities supporting medical affairs, patient advocacy groups, or external organizations (preferred)
Experience engaging with regulators, payors, and prescribers in relevant markets (preferred)
Experience integrating genetic data to inform clinical protocols (preferred)
Ability to apply statistical and data visualization methods to interpret complex information and support decision-making (preferred)
Experience using new digital tools and learning technologies to drive innovation (preferred)

Benefits

Comp & perks

Annual bonus
Eligibility to participate in share based long term incentive program
Health care and other insurance benefits for employee and family
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave
Reasonable adjustments and support for application or interview
Comprehensive benefits program for US employees