Reporting to the Head of Clinical Development, the CS will be acting as clinical reference in the Study team level, involved in the design, conduct, follow-up, data interpretation and reporting of early phase clinical trials, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance with Good Clinical Practice (GCP) and regulatory requirements. As part of an international team, the CS will contribute to the research and development of medicines in neurology, particularly in rare disease.

Responsibilities :

At study level       

•        Acts as the clinical referent for the study team

•        In collaboration with the Clinical Lead, designs the study and delivers the synopsis, protocol, consent form and amendments

•        Ensure appropriate staff training on studies (product, indication, rational as well as clinical aspects of the protocol)

•        Provide answers to clinical and medical questions especially for efficacy and safety (investigators, authorities, internal staff)

•        Anticipates issues regarding included population characteristics, blinded efficacy data and prepares action plans to ensure the fulfillment of the study objectives

•        Is a member of the clinical sub team

At project level

•        Prepares relevant sections of product/regulatory documents (e.g., investigator brochure, briefing book or periodic safety reports for health authorities, etc.)

•        Contributes to the publications, data presentation at scientific meetings and manuscript writing

Transversal

•        Can provide his/her medic-scientific expertise to internal and external working groups or initiatives

•        Masters the quality processes (internal SOPs, external guidelines)

Description du profil :

Profile:

Qualifications:

Ideally MD, or PharmD or PhD in biology with strong experience in Clinical development

Skills:

• Excellent verbal, written, communication and interpersonal skills.
• At ease with working in matrix organization (line management, functional management)
• Project oriented
• Ability to work autonomously and as part of a team
• Strong analytical skills and ability to summarize
• Ability to anticipate and to innovate
• Fluency in English

Experience:

• Minimum 3-years’ experience in clinical development
• Experience in medical monitoring of phase I/II clinical studies in industry, CRO, academic setting is suitable
• Experience in protocol writing and preparation of documents for clinical trial submission to regulatory authorities / ethic committees
• Experience in trial data analysis, interpretation, reporting and presentation (oral presentation, posters, publications)