Senior Medical Director, Clinical Development, Advanced Pipeline Unit; APU), Hepatology

GSK is seeking a highly skilled Senior Medical Director, Clinical Development, for an Advanced Pipeline Unit (APU) Hepatology group to provide clinical and scientific leadership for potential new, established and emerging indications for assets in clinical development with a strong focus on steatotic liver disease (SLD), including alcohol-associated liver disease (ALD). You will work with project teams to plan and ensure delivery of clinical research and development activities and establish efficient collaboration throughout all stages of development.

You will report to the Senior Director/Clinical Development Lead for an asset in the SLD therapeutic area. This role is pivotal in driving GSK’s mission to deliver transformative medicines to patients, ensuring clinical excellence, regulatory compliance, and operational efficiency. The successful candidate will not only deliver results but also inspire and empower teams to achieve exceptional outcomes.

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.

• Contribute to the clinical development strategy for a drug or program.
• Ensure execution of clinical development plans (CDP) for product(s) and/or indication(s) and provide strategic oversight and management of clinical trials.
• Lead clinical development activities from a therapeutic area and clinical trial perspective, including:
  Provide clinical and medical oversight of ongoing clinical trials Lead clinical trials and asset-level activities in a matrix team structure
• Identify and highlight transformational opportunities where projects can offer highly significant benefit to patients.
• Contribute to development of the Integrated Evidence Strategy (IES). Integrate scientific rationale, regulatory requirements, product development plans, and commercial goals to optimize asset indications and trials.
• Contribute to clinical development discussions and teams at global regulatory interactions. Draft clinical components of global regulatory submissions/files (e.g., IND, NDA, BLA, MAA), including briefing documents, presentations, and responses to regulatory questions.
• Promote innovative methodologies and processes including digital tools, encouraging others to think differently and adopt new ways of working.
• Stay abreast of advancements in therapeutic area research, clinical trial methodologies, competitive environment, and regulatory space to maintain GSK’s competitive edge.

#LI-GSK

• Medical degree and clinical medical specialty training board qualification/registration in Internal Medicine or Primary Medical.
• Experience in the global pharmaceutical/biotechnology industry in the field of Hepatology.
• Experience in clinical research and drug development, with a focus on SLD, including ALD and MASH.
• Experience in late-stage Hepatology drug development, including Phase 2 and Phase 3 clinical trial design, initiation, execution, and closure.
• Experience in medical monitoring activities and oversight.
• Experience in leading regulatory submissions and managing global clinical trials.
• Experience with ICH and GCP guidelines and regulatory requirements.
• Matrix team experience within a clinical development setting.

• Medical degree and clinical medical specialty training board qualification/registration in Hepatology/Gastroenterology, Endocrinology or Nephrology.
• Thorough…