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Medical Director, Clinical Development Hepatology

$222.75k - $371.25k
Full-time

Glaxosmithkline

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D We are seeking a Medical Director, Clinical Development Hepatology for a clinical program in hepatology. The Medical Director, Clinical Development will support the Clinical Development Lead (CDL) and clinical team to plan and execute a clinical program, consisting of late-stage studies in liver disease, with an opportunity to support multiple indications as part of this program’s life cycle management plans. You will work as part of a cross-functional team to deliver on a high-priority program, while also contributing to a dynamic and collaborative clinical research community. This role will provide you the opportunity to lead key activities to progress your career. About RIIRU: The Respiratory, Immunology and Inflammation Research Unit (RIIRU) 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 remit of RIIRU is to identify novel targets based on human genetics, develop assets for clinical studies, and perform trials through to submission for approvals. This goal is enabled through strategic external (e.g., Flagship Pioneering, Vesalius, Muna Therapeutics and others) and GSK-internal partnerships (Research Technologies). PLEASE NOTE: This career opportunity requires an on-site office presence (minimum of two days a week) at one of GSK’s US (PA or MA) or UK (Stevenage or London HQ) sites. Key Responsibilities: Supporting the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for asset(s) in development Ensuring alignment with and support of project strategic plans, regulatory requirements, and commercial goals, optimizing clinical study design aligned with IEP and CDP Generating the data and evidence required to determine a medicine’s potential efficacy, safety profile, key areas of product differentiation, and value to patients. Providing effective support and oversight of evidence generation activities to assure patient safety and study delivery. Enabling robust protocol design, including selection of clinical endpoints, patient populations, and participant monitoring strategy Working with Clinical Operations and Biostatics to deliver clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP Active medical monitoring activities and medical data review of ongoing studies, including: Lead, coordinate activities and present at IDMCs, adjudication committees, ongoing routine safety review Interpretation and presentation of clinical data for clinical study reports and publications Oversee and train study team on protocol-related activities in collaboration with matrix study team members Developing and maintaining relationships with program counterparts, including Commercial, Research, Regulatory, Clinical Operations, and Statistics Interfacing and influencing a diverse range of scientific external experts (e.g., regulators, payors, CROs, consultants, investigators) in order to deliver clinical programs, align to business strategy, and address patient needs. Gathering and supporting the integration of inputs from across disciplines (scientific, clinical, commercial, regulatory) to contribute to clinical components of the Medicine Profile Contributing to regulatory interactions including briefing documents, presentations, addressing questions and responses Serving as a clinical representative for senior management and senior level matrix teams, both internally and externally for an asset in development Contributing to the implementation and embedding of strategic initiatives and various organizational initiatives in RIIRU APU Supporting technical and leadership development of RIIRU APU staff via mentoring and coaching for matrix team members Support enterprise efforts to streamline and grow efficiencies for the business unit Basic Qualifications: We are looking for professionals with these required skills to achieve our goals Medical degree Clinical medical specialty training with board qualification/registration in Internal Medicine or Primary Care / Family Medicine. Completion of a full clinical residency program leading to board qualification or certification. Experience in clinical drug development, with understanding of clinical trial execution from concept to publication. Direct experience with in‑stream medical oversight activities during trial conduct. Knowledge of ICH guidelines, FDA requirements, and global regulatory expectations. Understanding of clinical research methodology and biostatistical principles to support innovative and efficient clinical trial design and data‑driven decision rules. Preferred Qualifications: If you have the following characteristics, it would be a plus: Medical degree plus completion of advanced clinical specialty training with board qualification/registration in Hepatology (or equivalent higher specialty training). Familiarity or experience in MASH or ALD drug development, disease biology, therapeutic targets, and current/future treatment landscape. Clinical research experience in hepatology, including clinical development planning and interventional study design. Experience with site‑facing interactions and/or activities supporting medical affairs, patient advocacy groups, or external organizations. Demonstrated ability to lead line or matrix teams, with a strong reputation for inspiring and motivating high performance. Experience engaging with regulators, payors, and prescribers in relevant markets. Experience integrating genetic data to inform clinical protocols. Proven ability to apply statistical and data visualization methods to interpret complex information, draw accurate conclusions, and support decision‑making. Experience using new digital tools and learning technologies to drive innovation. • If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $222,750 to $371,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process. 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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - View email address on click.appcast.io 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 (including family medical history), military service or any basis prohibited under federal, state or local law. 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 the Centers for Medicare and Medicaid Services (CMS) website at We are 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. Find out more on our career site.

Vacancy posted 4 days ago
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