Clinical Research Physician, Global Rare Diseases

4 ore fa

La Spezia, Liguria, Italia Chiesi Tempo pieno
Overview

In this role you drive clinical development by supporting global studies and ensuring scientific soundness. You work with cross-functional teams to shape trial design, endpoints and monitoring strategies, while interfacing with health authorities and external experts. You contribute to regulatory documents and publication plans, helping grow our rare-disease therapies. You join a mission-driven company committed to sustainable innovation and patient outcomes.

Retribuzione / Benefits
  • pension
  • private medical insurance
  • wellbeing programme
  • flexible benefits programme
  • ticket restaurant
  • relocation support
Responsabilità
  • Support the clinical team in medical and scientific aspects of global clinical studies within the development program
  • Contribute to risk/benefit assessments of ongoing trials and act as primary medical monitor for assigned studies
  • Contribute to production of regulatory documents (e.g., CTD) and represent the company to authorities and partners
  • Develop and enhance management of clinical trials in collaboration with the Clinical Program Leader to ensure validity of design, conduct and interpretation
  • Participate in program and study teams to support design, conduct, analysis and data interpretation with timely documentation
  • Conduct medical and scientific reviews of trial data with CPL oversight
  • Act as clinical expert in interactions with internal/external stakeholders and maintain knowledge of regulatory and disease-area developments
  • Interface with external scientific experts to align on program strategy and patient needs
  • Identify trends to support internal decision making and ensure timely publication of clinical data
  • Ensure robust, optimized trial designs and appropriate endpoints, monitoring, and adherence to SOPs and KPIs
  • Support post-registration studies to sustain product lifecycle and growth
Requisiti fondamentali
  • Medical Doctor degree
  • 2+ years of experience as Clinical Research Physician/Medical Monitor in pharma or CROs
  • Experience in clinical research in rare diseases or clinical development (trial design, conduct, interpretation)
  • Interpersonal communication
  • Stakeholder management
  • Cross-functional collaboration
  • Clinical trial design and interpretation
  • Regulatory knowledge (health authorities, guidelines)
  • Medical monitoring and data interpretation