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Project Physician – Clinical Development Lead

GSK · Sienne

Nouveau
Tempo indeterminato 🇬🇧 English

Description du poste

About the role

The Project Physician will lead the clinical development of one or more vaccine programmes, ensuring high‑quality data generation and on‑time delivery of proof‑of‑concept results. This senior medical role sits within the GVGH vaccine development team in Siena, Italy.

Key responsibilities

  • Design and set‑up GVGH‑managed clinical trials for vaccine candidates.
  • Author and contribute to clinical and epidemiology plans, protocols, investigator brochures, study reports and regulatory submissions.
  • Provide medical monitoring for clinical trials, including review of medical data listings and assessment of serious adverse events.
  • Participate in the Safety Review Team, overseeing safety assessments and case safety report compliance.
  • Collaborate with cross‑functional teams (clinical operations, biostatistics, regulatory) and external CROs.
  • Represent GVGH in meetings with health authorities, scientific community and international agencies.
  • Contribute to the creation and revision of SOPs, work instructions and other standards.

Required profile

  • Medical degree with experience in vaccine clinical development.
  • Strong knowledge of Good Clinical Practice (GCP) and regulatory requirements.
  • Experience in medical monitoring, safety assessment and handling of adverse events.
  • Ability to work within cross‑functional, multi‑disciplinary teams.
  • Proficiency in clinical trial methodology and drug safety competencies.

Required skills

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