Medical Director, Clinical Development, Advanced Pipeline Unit (APU), Hepatology

Role Summary

Medical Director, Clinical Development for the Advanced Pipeline Unit (APU) Hepatology at GSK. Provides clinical and scientific leadership for hepatology assets across potential indications, with a focus on steatotic liver disease and alcohol-associated liver disease. Leads development activities with project teams to plan and deliver clinical research and development programs, ensuring regulatory compliance and operational excellence. Reports to the Senior Director/Clinical Development Lead for the asset in the SLD therapeutic area.

Responsibilities

• 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.
  • 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.

Qualifications

• Required: Medical Degree
• Required: Completion of a full clinical residency program leading to board qualification or certification
• Required: Experience in the global pharmaceutical/biotechnology industry
• Required: Experience in clinical research and drug development
• Required: Experience in medical monitoring activities and oversight
• Required: Experience in leading regulatory submissions and managing global clinical trials
• Required: Experience with ICH and GCP guidelines and regulatory requirements
• Required: Matrix team experience within a clinical development setting
• Preferred: Medical degree and clinical medical specialty training board qualification/registration in Hepatology strongly preferred
• Preferred: Thorough understanding of SLD, including ALD and MASH, the underlying biology and potential therapeutic targets
• Preferred: Experience in late-stage Hepatology drug development, including Phase 2 and Phase 3 clinical trial design, initiation, execution, and closure
• Preferred: Solid understanding of needs and priorities of regulators, payers and prescribers in relevant global market(s)
• Preferred: Track record of building and maintaining strong relationships with internal and external stakeholders
• Preferred: Demonstrated strong problem-solving skills and innovative thinking; ability to anticipate challenges, develop strategic approaches, and communicate uncertainty to stakeholders while guiding teams through unclear circumstances
• Preferred: Enterprise mindset; identifying opportunities for synergy across the organization
• Preferred: Strategic thinking to analyze, interpret, and critically evaluate complex data; ability to anticipate obstacles and identify innovative solutions to support regulatory approvals and patient benefit
• Preferred: Ability to navigate ambiguity by anticipating regulatory challenges and proactively addressing issues
• Preferred: Experience of clinical research methodology and biostatistics to facilitate innovative and efficient designs of clinical trials and clinical development plans with data-driven decision rules

Additional Requirements

• On-site presence required (minimum two days per week) at one of GSK's US or UK sites: PA or MA (USA) or Stevenage or London (UK)