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Executive Medical Director, Hepatology at GSK Cambridge, MA

Itlearn360

Executive Medical Director – Hepatology Location: Cambridge, MA (GSK HQ), Stevenage, UK, Upper Providence, PA. Posted: Sep 26, 2025. Key Responsibilities Provide medical and scientific leadership for a hepatology asset, driving strategy to achieve clinical, regulatory, and commercial milestones while ensuring alignment with GSK’s strategic priorities. Oversee the design, initiation, execution, and closure of late‑stage clinical trials, including Phase 3 studies, ensuring delivery of high‑quality data to support regulatory approval and commercialization. Lead critical regulatory activities, including dossier submissions, preparation for meetings with health authorities (e.g., FDA, EMA, PMDA), and responses to regulatory queries. Identify, develop, and execute strategies to expand the asset beyond its primary indication, exploring life‑cycle opportunities to maximize therapeutic and commercial potential. Partner with cross‑functional teams—including clinical, translational, commercial, regulatory, and scientific—to advance the asset. Monitor emerging trends, competitor activities, and advancements in hepatology to identify opportunities for differentiation and strategic growth. Lead and mentor a high‑performing team, fostering professional development, providing clear direction, and ensuring alignment with GSK’s values and objectives. Act as a key representative of GSK’s RIIRU in hepatology, engaging with external stakeholders, scientific forums, and professional organizations. Basic Qualifications Medical degree and clinical medical specialty training with board qualification/registration. Experience in the global pharmaceutical/biotechnology industry in hepatology. Experience in clinical research and drug development with a focus on hepatology. Line‑management experience overseeing medical directors and/or clinical scientists, and leading matrix teams within a clinical development setting. Experience in late‑stage hepatology drug development, including Phase 2 and Phase 3 clinical trial design, initiation, execution, and closure. Preferred Qualifications Medical degree and specialty training in Gastroenterology or Hepatology. Demonstrated success in life‑cycle management, including indication expansion and strategic development. Experience with regulatory interactions, including submissions, strategy meetings, and negotiations with health authorities. Understanding of the clinical and scientific landscape in hepatology and experience advancing innovative therapies. Experience in translational medicine and biomarker development. Benefits: GSK offers a comprehensive benefits program for US employees. 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, military service or any basis prohibited under federal, state or local law. #J-18808-Ljbffr Itlearn360

Vacancy posted 3 days ago
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