Clinical Development Medical Director - Hepatology

Job Overview

GSK is seeking a Clinical Development Medical Director - Hepatology to act as a translational leader within the Early Pipeline Unit (EPU) of the Respiratory, Immunology and Inflammation Research Unit (RIIRU). The successful individual will provide medical and scientific expertise to pre clinical, clinical and translational studies and will lead programs or work within project teams to conceptualise, design, plan and execute projects including first time in human trials for new assets, experimental medicine studies and translational data generation. They will work cross functionally to develop and execute clinical development plans up to, and including, Proof of Mechanism/Proof of Concept studies, focusing on steatotic liver disease (including MASH and ALD) and chronic Hepatitis B.

Key Accountabilities / Responsibilities

• Drive development of clinical plans and study designs, ensuring alignment with translational plans and project strategies to ensure quality execution.
• Generate data and evidence required to determine target or medicine potency, safety profile, product differentiation and route to market.
• Deliver clinical development timelines and endpoints, including pharmacology, mechanism and efficacy endpoints, enabling key decision points and Go/No Go criteria.
• Maintain relationships with program counterparts in Biology, Translational, Commercial, Research, Regulatory, Clinical Operations, Access, Medical Affairs and Statistics.
• Contribute to the implementation of strategic initiatives and organisational initiatives in Clinical Development.

Clinical Development Strategy; Study & Program Design

• Design clinical development plans and study protocols across all phases, reflecting stakeholder input.
• Develop clinical study protocols, amendments, investigator brochures and reports.
• Contribute to indication planning and deliverables such as early Medicine Profile and Target Validation.
• Provide support and oversight of R&D evidence generation activities to assure safety and study delivery.
• Input to regulatory interactions and documents including briefing materials and responses.

Clinical Leadership

• Lead end to end clinical development strategy for an EPU program and the clinical matrix team.
• Collaborate with cross functional teams to ensure cohesive translational and clinical plans. Act as Clinical Lead at study level.
• Act as primary clinical interface with internal review boards and governance bodies.
• Evaluate business development opportunities and stay abreast of advances in hepatology, trial methodologies and regulatory space.

Influencing and Inspiring Others, Managing Conflict

• Inspire teams by setting a positive example and communicating a compelling vision.
• Manage conflicts effectively and negotiate mutually acceptable solutions.
• Achieve desired outcomes through strong influencing skills tailored to the audience.

Enterprise Mindset and Navigating Ambiguity

• Adaptability in changing environments, analyzing incomplete information and making informed decisions.
• Collaborate across the matrix, integrating cross functional knowledge into decision making and balancing team and business goals.
• Embrace challenges as opportunities for innovation and encourage others to generate improvement ideas.

Qualifications

• Medical Degree required; general internal medicine or relevant disease area experience preferred.
• Completion of clinical residency and specialty training, ideally including hepatology experience.
• Experience in pre clinical or clinical R&D (may include post grad experience).
• Knowledge of translational study execution and human translational data analysis, and pre clinical biomedical experiments.
• Robust knowledge of hepatology research priorities, public health needs, competitor landscape, clinical practice trends and guideline evolution.
• Knowledge of regulatory requirements, Good Clinical Practice (GCP) and ethical guidelines for clinical research.

Preferred Qualifications

• PhD or other higher research degree.
• Board certified/eligible in gastroenterology with focus in hepatology.
• Experience managing global regulatory agencies and global hepatology trials.

Salary & Benefits

• If based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA: annual base salary range $222,750 to $371,250.
• If based in another US location: annual base salary range $202,500 to $337,500.
• Position offers an annual bonus and eligibility to participate in a share based long term incentive program.
• Benefits include health care and other insurance, retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

Equal Opportunity Employer

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.