Executive Director Clinical Research - Hepatology

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Executive Director Clinical Research - Hepatology

Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, UK - London - New Oxford Street, USA - Massachusetts - Waltham
Posted Date: Dec 18 2024

GSK is seeking a dynamic and experienced Executive Director Clinical Research for Hepatology Clinical Trials to lead our clinical development programs within the hepatology therapeutic area. This role will involve strategic oversight, leadership, and management of clinical trials, ensuring scientific integrity and adherence to regulatory requirements. This position reports to the VP Clinical Research Head, Hepatology- Clinical Research and Early Programs in the Respiratory and Immunology Research Unit (RIRU). This career opportunity requires an on-site office presence (minimum of two days a week) in one of GSK's UK (London - New Oxford Street or Stevenage) or US (PA or MA) sites.

About RIRU:

The Respiratory & Immunology Research Unit (RIRU) was formed in 2024 to identify and advance novel molecular targets with genetic associations to disease based on the foundational observation that targets with human genetic evidence supporting their causal role in the intended indication improves clinical success by two-fold. The biology unit within RIRU (aka RIBU) works across multiple therapy areas including neurodegenerative, immune, and metabolic disease. The remit of RIRU is to identify novel targets based on human genetics, develop assets for clinical studies, and perform up to Phase 2 studies in clinic.

Key Responsibilities:

• Provide strategic leadership and direction for the design, execution, and management of clinical trials in hepatology.
• Oversee the development and implementation of clinical trial protocols, ensuring alignment with regulatory requirements and GSK's scientific standards.
• Collaborate with cross-functional teams, including research, regulatory affairs, medical affairs, and commercial teams, to ensure cohesive and comprehensive clinical development plans.
• Serve as the primary point of contact for internal and external stakeholders, including regulatory agencies, key opinion leaders, and clinical investigators.
• Ensure the integrity, safety, and efficacy of clinical trials through rigorous monitoring, data analysis, and risk management.
• Lead and mentor clinical professionals, fostering a culture of innovation, collaboration, and excellence.
• Manage senior clinical scientists and physician scientists (direct reports) working on hepatology assets.
• Stay abreast of advancements in hepatology research, clinical trial methodologies, and regulatory changes to maintain GSK's competitive edge.
• Contribute to above asset hepatology strategy.
• Assist in clinical evaluation of business development opportunities.
• Represent GSK in scientific meetings, conferences, and industry forums to advance our hepatology clinical research initiatives.

Basic Qualifications:

• Medical degree with board certification/eligibility or registration qualifications in gastroenterology/hepatology.
• Experience in the pharmaceutical/biotechnology industry and/or clinical academic medicine in the field of hepatology. Minimum of 10 years of experience clinical research and development, with a focus on hepatology or related therapeutic areas.
• Regulatory experience to support product registration and GCP principles.
• Experience successfully leading and managing clinical trials.
• Experience with regulatory requirements, Good Clinical Practice (GCP), and ethical guidelines for clinical research.

Preferred Qualifications:

• Experience (minimum 5 years) working with global regulatory agencies and managing global clinical trials in hepatology.
• Leadership/People Management experience in clinical practice, academia and/or industry.
• PhD, Pharm D and/or MPH in addition to MD (or equivalent).
• Robust knowledge of hepatology-specific research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution.
• Leadership of a global clinical development program in the biopharmaceutical industry.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.