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Clinical Development Director – Hepatology

3-8 years
Not Disclosed
10 Nov. 26, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Development Director – Hepatology

Location: Multiple (Stevenage, UK; London, UK; Boston, MA, USA; Collegeville, PA, USA)
Job Type: Full-Time
Category: Medical & Clinical
Job ID: 427113


About the Role

GSK is seeking an experienced and strategic Clinical Development Director – Hepatology to lead clinical and translational development programs within the Early Pipeline Unit (EPU) of the Respiratory, Immunology, and Inflammation Research Unit (RIIRU). The role focuses on advancing clinical development strategies and studies, particularly in steatotic liver disease (SLD), from early translational research to proof-of-concept trials.

This leadership position provides the opportunity to shape global hepatology programs, influence clinical strategy, and collaborate across multiple disciplines, including regulatory, medical affairs, commercial, and clinical operations.


Key Responsibilities

  • Lead and provide clinical and scientific oversight for hepatology programs within the EPU.

  • Align translational and clinical study plans with project strategies, ensuring high-quality execution of Clinical Development Plans (CDPs).

  • Develop and deliver clinical development strategies, including study design, endpoints, and decision criteria.

  • Oversee generation and analysis of translational and clinical data to support efficacy, safety, and product differentiation.

  • Collaborate cross-functionally with Biology, Translational, Regulatory, Medical Affairs, and Commercial teams.

  • Develop clinical study protocols, amendments, investigator brochures, clinical study reports, and regulatory documents.

  • Provide medical monitoring and oversight of participant safety in coordination with Pharmacovigilance teams.

  • Serve as the clinical point of contact internally and externally, representing programs with stakeholders, regulators, and key opinion leaders.

  • Monitor hepatology research trends, clinical methodologies, and competitive landscape to identify opportunities for innovative patient care.

  • Contribute to business development evaluations and strategic organizational initiatives.


Required Experience & Qualifications

  • PhD, PharmD, or equivalent with at least 3–5 years of post-graduate clinical research experience.

  • Minimum of 5–8 years of experience in clinical development, translational research, or drug development, preferably in hepatology.

  • Robust knowledge of hepatology research priorities, clinical practice trends, public health needs, and treatment guidelines.

  • Experience in global regulatory interactions and managing multinational clinical trials.

  • Knowledge of Good Clinical Practice (GCP), ethical guidelines, and regulatory requirements.

  • Demonstrated ability to lead cross-functional teams, influence stakeholders, and drive clinical development strategies in a matrixed organization.


Preferred Qualifications

  • Medical degree with board certification or eligibility in hepatology.

  • Background in general internal medicine for MDs or equivalent disease-area experience.

  • Proven success in early clinical program leadership, including proof-of-mechanism or proof-of-concept studies.


Compensation & Benefits

  • Competitive base salary and annual performance-based bonus.

  • Flexible working options available for most roles.

  • Comprehensive healthcare and wellbeing programs.

  • Learning and career development opportunities.

  • Employee recognition programs.


Why GSK?

GSK unites science, technology, and talent to get ahead of disease together. Our mission is to improve the health of billions globally by advancing specialty medicines and vaccines. We foster a culture of ambition for patients, accountability, integrity, and teamwork, enabling employees to thrive and make a global impact.

GSK is an Equal Opportunity Employer, ensuring fair consideration for all qualified applicants, regardless of race, color, religion, sex, gender identity, sexual orientation, parental status, national origin, age, disability, or any other legally protected category.


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