Medical Director, Clinical Development, Hepatology

Regulatory Toolkit; Waltham (MA); Hybrid; USD 161,000 - 241,000; Full time

Job summary

GSK is seeking a Medical Director, Clinical Development with a strong focus on hepatology to provide clinical and scientific guidance across asset development from early concepts to registrational studies. You will collaborate with project teams to design trials, ensure safety, and support regulatory interactions.

The role sits within RIIRU, operates on a hybrid model with on-site presence required several days per week, and involves leading complex global studies and regulatory submissions.

Qualifications

• Medical degree required.
• 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.

Responsibilities

• Lead clinical development activities up to registrational studies.
• Provide medical monitoring and oversight of patient safety during the study.
• Act as clinical lead for a study and be the clinical point of contact.
• Contribute to global regulatory submissions and briefing documents.
• Collaborate with cross-functional teams across disciplines to meet study milestones.

Skills

Medical degree

Clinical specialty training

Residency for board qualification

Pharma industry experience

Medical oversight activities

Job description

For candidates seeking to be located at our Stevenage site, this role will temporarily be based at Stevenage. However, the Company plans to relocate its offices to Cambridge, UK. The location of this role will therefore subsequently change to Cambridge, UK in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029.

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

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).

Working model

This role is hybrid. You will be on-site at one of the posted locations at least two days per week. Remote work is available on other days.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• 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.

Additional Responsibilities

• 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.

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 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