Hybrid Medical Director – Hepatology, Clinical Development

Women In Bio; Central (PA); Hybrid; USD 223,000 - 371,000; Full time

Job summary

GSK is seeking a Medical Director, Clinical Development, Hepatology to provide clinical and scientific insights to assets in development with a strong liver focus. You will lead cross‑functional teams to plan, execute, and deliver development activities up to registrational studies, reporting to the Clinical Development Lead, ensuring clinical excellence, regulatory compliance, and operational efficiency.

The role includes leading study leadership teams, contributing to global regulatory

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

Responsibilities

• Contribute to project team discussions on indication planning and incorporate input from across disciplines to support deliverables (TPP, CDP, protocols, 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 input from patients, regulators, payors, and others.
• Lead regulatory interactions and documents including briefing documents, presentations, and responses for assigned studies and programs.
• Provide medical monitoring and oversight of participant safety during the study, in collaboration with Pharmacovigilance Physician.
• Act as clinical lead for a clinical study and serve as clinical point of contact for a study within the Clinical Matrix Team across internal and external stakeholders.
• Make significant contributions to global regulatory submissions/files (IND, NDA, BLA, MAA) including briefing documents and responses to questions.
• Evaluate Business development activities including due diligence and contribute to strategic initiatives in Clinical Development.
• Stay abreast of advancements in therapeutic area research, clinical trial methodologies, regulatory space to maintain GSK's competitive edge.

Skills

Clinical Development

Communication

Drug Regulatory Affairs

Evidence Based Decision Making

Good Clinical Practice

Influencing Without Authority

Learning Agility

People Management

Project Management

Scientific Presentations

Strategic Thinking

Education

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

Job description

GSK is seeking a Medical Director, Clinical Development, Hepatology to provide clinical and scientific insights to assets in development with a strong liver focus. You will lead cross‑functional teams to plan, execute, and deliver development activities up to registrational studies, reporting to the Clinical Development Lead, ensuring clinical excellence, regulatory compliance, and operational efficiency.

The role includes leading study leadership teams, contributing to global regulatory