Senior Medical Director, Clinical Development, Hepatology in London

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 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 drives clinical excellence, regulatory compliance and operational efficiency, with an emphasis on inspiring and empowering teams to achieve exceptional outcomes.

Key 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.
• 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.

Basic Qualifications:

• 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.

Preferred Qualifications:

• Medical degree and clinical medical specialty training board qualification/registration in Hepatology/Gastroenterology, Endocrinology or Nephrology.
• Thorough understanding of SLD, including ALD and MASH, the underlying biology and potential therapeutic targets.
• Solid understanding of needs and priorities of regulators, payers and prescribers in relevant global market(s).
• Track record of building and maintaining strong relationships with internal and external stakeholders.
• Demonstrated strong problem-solving skills and innovative thinking. Anticipate potential challenges, develop strategic approaches, and effectively communicate uncertainty to stakeholders while guiding teams through unclear circumstances.
• Have an enterprise mindset by identifying opportunities for synergy across the organization.
• Ability to use strategic thinking to analyze, interpret, and critically evaluate complex data and information. Anticipate obstacles and identify innovative solutions to ensure timely delivery of evidence that supports regulatory approvals and patient benefit.
• Navigate ambiguity by anticipating regulatory challenges and proactively addressing issues.
• Experience of clinical research methodology and principles of biostatistics to facilitate innovative and efficient designs of clinical trials and clinical development plans with clear data-driven decision rules.

Salary ranges vary by location, with specific figures provided for certain US locations and an acknowledgment that other locations may have different ranges. The role includes an annual bonus and eligibility for long-term incentives, as well as comprehensive benefits.

Why GSK?

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. Our focus areas include respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. We are committed to creating an environment where our people can thrive, and to a culture of being ambitious for patients, accountable for impact, and doing the right thing.