Hepatology Clinical Development Director

GlaxoSmithKline; Boston (MA); Hybrid; USD 202,500 - 371,250; Full time

Job summary

GlaxoSmithKline seeks an experienced Medical Director for Clinical Development in Hepatology within the RIIRU. You will lead medical and scientific expertise for target validation, translational plans, and early development programs to demonstrate proof of concept and drive lifecycle opportunities.

You will provide medical governance across projects, oversee safety, and collaborate with regulatory and external partners to advance liver disease programs, delivering robust CDPs and study timelines

Qualifications

• Medical Degree and formal postgraduate clinical training in Internal Medicine, Pathology, etc.
• Demonstrated experience in clinical trial conduct, medical monitoring, safety review, and data interpretation
• Strong working knowledge of clinical development processes, including GCP, ICH guidelines, and global regulatory frameworks
• Ability to apply clinical judgement to support study design, patient safety and real-time medical decision-making within a structured clinical development framework
• Experience operating effectively within cross-functional matrix teams in pharma/biotech/academic trials
• Strong scientific communication skills with ability to translate clinical data into clear insights for internal and external audiences

Responsibilities

• Provide medical governance across the project to ensure scientific integrity and safety of study subjects.
• Lead the Clinical Matrix Team (CMT) for a program and serve as the clinical point of contact for stakeholders.
• Design clinical development plans, study protocols and associated documents across all phases of development.
• Attend regulatory interactions and prepare briefing documents and responses for assigned studies.
• Provide medical monitoring and safety oversight of study participants.
• Agree and deliver clinical pillars of the translational table and CDP timelines/endpoints.

Skills

Clinical Development

Communication

Drug Regulatory Affairs

Evidence Based Decision Making

GCP

Influencing Without Authority

Learning Agility

People Management

Project Management

Scientific Presentations

Strategic Thinking

Education

Medical Degree

Job description

GlaxoSmithKline seeks an experienced Medical Director for Clinical Development in Hepatology within the RIIRU. You will lead medical and scientific expertise for target validation, translational plans, and early development programs to demonstrate proof of concept and drive lifecycle opportunities.

You will provide medical governance across projects, oversee safety, and collaborate with regulatory and external partners to advance liver disease programs, delivering robust CDPs and study timelines