Medical Director, Clinical Development, Hepatology

GSK•Boston, MA

21h•$202,500 - $371,250•Hybrid

About The Position

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 Position Summary: A Medical Director, Clinical Development, Hepatology is sought to provide clinical and scientific insights to potential new, established and emerging assets in clinical development with a strong focus on liver diseases. You will work within project teams to plan, execute, and deliver clinical development activities up to and including registrational studies. You will report to the Clinical Development Lead. This role is pivotal in driving GSK’s mission to deliver transformative medicines to patients, ensuring clinical excellence, regulatory compliance, and operational efficiency. 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.

Requirements

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 working in the pharmaceutical industry 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.

Nice To Haves

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.

Responsibilities

Contribute to project team discussions on indication planning and incorporate input from across disciplines (scientific, clinical, commercial, regulatory, stats, etc) to support vital deliverables including the Target Product Profile (TPP), clinical development plan (CDP), study protocols, and integrated evidence strategy (IES) and planning.
Provide effective support to the development and execution of the IES, including oversight of R&D evidence generation activities to ensure patient safety and study delivery.
Design and execute clinical development plans across advanced stages of development, reflecting internal and external stakeholder input (ie patients, evidence generation, regulators, payors, pharmacovigilance, etc.).
Contribute to ambitious clinical development timelines by overseeing development of clinical study protocols, amendments, investigator brochures, clinical study reports etc.
Input to, and may lead, regulatory interactions and documents including briefing documents, presentations, addressing questions and responses for assigned studies and programs.
Provide medical monitoring and oversight of the safety of study participants on behalf of the Sponsor during the study, together with Pharmacovigilance Physician.
If physician, accountability for Medical Governance across the project to ensure scientific integrity and overall safety of the study subjects across the study.
Act as clinical lead for a clinical study, taking a key role on the Study Leadership Team (SLT) and serve as clinical point of contact for a clinical study on the Clinical Matrix Team (CMT), across the internal matrix and a broad range of external experts (e.g., regulators, payors, CROs, consultants, investigators).
Make significant contributions to global regulatory submissions/files (e.g., IND, NDA, BLA, MAA), including briefing documents, presentations, and responses to regulatory questions.
Evaluate specific business development activities, including due diligence and contributes to the implementation and embedding of strategic/organizational initiatives in Clinical Development, adopting innovative methodologies and processes including digital tools and technology.
Stay abreast of advancements in therapeutic area research, clinical trial methodologies, competitive environment, and regulatory space to maintain GSK’s competitive edge.
Demonstrate flexibility and adaptability in changing environments, able to analyze incomplete information, identify potential risks and implications, and make informed decisions.
Demonstrate enterprise mindset with effective collaboration across the matrix, able to integrate cross-functional knowledge into decision-making processes and balance team objectives with the wider business goals.
Embrace challenge as an opportunity, proactively generating ideas for innovative improvement and promoting an environment for others to be creative.
Manage conflicts effectively and independently, negotiating mutually acceptable solutions.
Analyze, interpret and critically evaluate data, information and digital content to interpret complex information, anticipate obstacles and identify potential solutions.
Consistently achieve desired outcomes through strong influencing skills including understanding others' perspectives, building trust, tailoring communications depending on the audience and using persuasive arguments to gain support.