Executive Director, Regulatory Science
Orchard Therapeutics
Executive Medical Director, Hepatology
GSK
full-time
Posted on:
Location Type: Hybrid
Location: Cambridge • Massachusetts, Pennsylvania • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- Lead an expanding hepatology program and advance an asset through late-stage development while exploring life-cycle management opportunities.
- Provide medical and scientific leadership for a hepatology asset, driving strategy to achieve clinical, regulatory, and commercial milestones.
- Oversee design, initiation, execution, and closure of late-stage clinical trials including Phase 3 studies to deliver high-quality data for regulatory approval and commercialization.
- Lead global regulatory activities including dossier submissions, preparation for meetings with health authorities (FDA, EMA, PMDA), and responses to regulatory queries.
- Identify, develop, and execute life-cycle management strategies to expand the asset beyond its primary indication.
- Collaborate across clinical, translational, commercial, regulatory, and scientific cross-functional teams within a complex matrix.
- Monitor emerging trends, competitor activities, and advancements in hepatology to identify differentiation and strategic growth opportunities.
- Lead and mentor a high-performing team, fostering professional development and alignment with GSK values and objectives.
- Act as an external representative of GSK's RIIRU in hepatology, engaging with stakeholders, scientific forums, and professional organizations.
Requirements
- Medical degree and clinical medical specialty training board qualification/registration.
- Experience in the global pharmaceutical/biotechnology industry in the field of 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: Medical degree and clinical medical specialty training board qualification/registration in Gastroenterology or Hepatology.
- Preferred: Demonstrated success in life-cycle management, including indication expansion and strategic development beyond primary indications.
- Preferred: Experience with regulatory interactions, including submissions, strategy meetings, and negotiations with health authorities.
- Preferred: Understanding of the clinical and scientific landscape in hepatology and experience in advancing innovative therapies.
- Preferred: Experience in translational medicine and biomarker development.
- Requirement: On-site office presence (minimum of two days a week) in one of GSK’s US (PA or MA) or UK (London - New Oxford Street or Stevenage) sites.
Benefits
- Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical researchdrug developmentlate-stage clinical trialsPhase 2 clinical trial designPhase 3 clinical trial designlife-cycle managementregulatory submissionsbiomarker developmenttranslational medicinehepatology
Soft skills
leadershipmentoringcollaborationstrategic thinkingcommunicationteam managementprofessional developmentstakeholder engagementalignment with valuesmonitoring trends
Certifications
medical degreeclinical medical specialty training board qualification/registrationGastroenterology board certificationHepatology board certification
