Hepatology Clinical Development Lead

GlaxoSmithKline; Allentown (Lehigh County); Hybrid; USD 223,000 - 371,000; Full time

Job summary

GlaxoSmithKline seeks a Medical Director, Clinical Development, Hepatology to provide clinical and scientific insights for liver disease assets. You will work within project teams to plan, execute, and deliver development activities up to registrational studies, reporting to the Clinical Development Lead.

The role is hybrid, with on-site presence at participating locations two days per week and remote work on other days.

Qualifications

• Medical degree and board qualification/registration in Internal Medicine or Primary Care / Family Medicine.
• Experience in pharmaceutical industry in clinical drug development.
• Experience with regulatory submissions and medical affairs activities.
• Knowledge of ICH guidelines, FDA requirements, and global regulatory expectations.

Responsibilities

• Provide clinical and scientific insights for potential assets in clinical development up to registrational studies (report to Clinical Development Lead).
• Lead or contribute to development of the Target Product Profile (TPP), CDP, protocols and IES planning.
• Oversee safety monitoring and pharmacovigilance activities during trials in collaboration with PV Physician.
• Lead regulatory interactions and preparation of briefing documents, presentations, and responses to questions.
• Support global regulatory submissions/files (IND, NDA, BLA, MAA) and due diligence for business development.
• Stay abreast of trials methods, regulatory space and new digital tools to drive innovation.

Skills

Clinical research

Regulatory understanding

Medical governance

Biostatistics basics

Cross-functional collaboration

Strategic thinking

Education

Medical degree

Job description

GlaxoSmithKline seeks a Medical Director, Clinical Development, Hepatology to provide clinical and scientific insights for liver disease assets. You will work within project teams to plan, execute, and deliver development activities up to registrational studies, reporting to the Clinical Development Lead.

The role is hybrid, with on-site presence at participating locations two days per week and remote work on other days.