Senior Hepatology Clinical Development Lead

GlaxoSmithKline plc; Cambridge; On-site; GBP 150,000 - 200,000; Full time

Job summary

GlaxoSmithKline plc is seeking an Associate Director – Clinical Development to provide medical and scientific leadership for hepatology trials (Ph1–Ph4). You will oversee protocol development, safety monitoring, and regulatory documentation while ensuring alignment with the Clinical Development Plan.

The role involves cross-functional collaboration with Global Study Management, Biostatistics, Safety, and Regulatory teams, and requires MD or equivalent with hepatology experience.

Qualifications

• MD or equivalent medical degree required with hepatology or related liver disease exposure.
• Experience in clinical development of pharma/biotech or academic trials.
• Strong knowledge of GCP, ICH guidelines, and regulatory frameworks.

Responsibilities

• Lead or co-lead hepatology protocol development and amendments (Ph1–Ph4).
• Provide core medical input for eligibility, endpoints and safety monitoring.
• Author or oversee IBs, ICFs, CRFs and CSRs for hepatology studies.
• Ensure accuracy and consistency across study documentation.
• Serve as study medical monitor with day-to-day safety oversight.
• Contribute to safety reviews, signal detection, risk-benefit assessments.

Skills

Agile Thinking

Clinical Development

Clinical Trial Designs

Decision Making

Fostering Collaboration

Influencing Without Authority

Leadership

Matrix Leadership

Mentorship

People Management

Project Management

Risk Management

Strategic Thinking

Teamwork

Time Management

Education

MD or equivalent medical degree

Bachelor’s degree in life sciences or related discipline

Job description

GlaxoSmithKline plc is seeking an Associate Director – Clinical Development to provide medical and scientific leadership for hepatology trials (Ph1–Ph4). You will oversee protocol development, safety monitoring, and regulatory documentation while ensuring alignment with the Clinical Development Plan.

The role involves cross-functional collaboration with Global Study Management, Biostatistics, Safety, and Regulatory teams, and requires MD or equivalent with hepatology experience.