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

Role Summary

Senior Medical Director, Clinical Development for the Advanced Pipeline Unit (APU) in Hepatology, 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). Works with project teams to plan and ensure delivery of clinical research and development activities, establishing efficient collaboration throughout development stages. Reports to the Senior Director/Clinical Development Lead for an asset in the SLD therapeutic area and drives clinical excellence, regulatory compliance, and operational efficiency while inspiring teams to achieve exceptional outcomes. On-site presence is required (minimum two days per week) at one of GSK’s US or UK sites.

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) with 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 competitive edge.

Qualifications

• Required: Medical degree and clinical medical specialty training board qualification/registration in Internal Medicine or Primary Medical.
• Required: Experience in the global pharmaceutical/biotechnology industry in the field of Hepatology.
• Required: Experience in clinical research and drug development, with a focus on SLD, including ALD and MASH.
• Required: Experience in late-stage Hepatology drug development, including Phase 2 and Phase 3 clinical trial design, initiation, execution, and closure.
• 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/Gastroenterology, Endocrinology or Nephrology.
• Preferred: Thorough understanding of SLD, including ALD and MASH, the underlying biology and potential therapeutic targets.
• Preferred: Understanding of regulators, payers and prescribers in global markets.
• Preferred: Track record of building and maintaining strong relationships with internal and external stakeholders.
• Preferred: Problem-solving skills and innovative thinking; ability to anticipate challenges and guide teams through uncertainty.
• Preferred: Enterprise mindset and ability to identify cross-organizational opportunities.
• Preferred: Strategic data analysis and interpretation to support regulatory approvals and patient benefit.
• Preferred: Ability to navigate ambiguity and address regulatory challenges proactively.
• Preferred: Experience in clinical research methodology and biostatistics to enable innovative trial designs with data-driven decision rules.
• Note: For candidates based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary ranges from $284,625 to $474,375. For other US locations, salary range may vary.

Additional Requirements

• On-site presence required (minimum two days per week) at one of the specified sites.