Executive Director Clinical Research - Hepatology

Job highlights
Identified by Google from the original job post
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
This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements
Responsibilities
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)
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
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
Job description
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. Neurodegenerative disease portfolio includes projects in Alzheimer’s, Parkinson’s, and ALS. 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. This goal is enabled through strategic external (23andMe, UK Biobank, FinnGen, Laboratory of Genomic Research, Public-Private Consortia like Accelerated Medicines Partnership, GSK-Oxford University joint Institute for Molecular and Computational Medicine, Biotech partnerships – Alector, Vesalius, Muna Therapeutics) and GSK-internal partnerships (Research Technologies).

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.

Why You?

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.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-6+4-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, ****** orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.

United States
Pennsylvania
Collegeville Show on map Get directions