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.

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.

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.

#LI-GSK

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.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at HR.AmericasSC-CS@gsk.com where you can also request a call.

Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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