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

Role Summary

Senior Medical Director, Clinical Development, for an Advanced Pipeline Unit (APU) Hepatology group, providing clinical and scientific leadership for new, established and emerging indications in development with a focus on steatotic liver disease (SLD) including alcohol-associated liver disease (ALD). Lead planning and delivery of clinical research and development activities, drive collaboration across development stages, and report to the Senior Director/Clinical Development Lead for SLD. Aim to deliver transformative medicines with clinical excellence, regulatory compliance, and operational efficiency, inspiring teams to achieve exceptional outcomes.

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.

Qualifications

• Required: 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: 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.

• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $284,625 to $474,375.
• If you are based in another US location, the annual base salary range is $0 to $0.

Additional Requirements

• On-site office presence required (minimum of two days a week) at one of GSK’s US (PA or MA) or UK (Stevenage or London HQ) sites.