Spring Life Sciences is looking for his client a

lausanneFixe2018-09-27Non exigé / Non qualifié
Medical Director

Spring Life Sciences is looking for his client a

The Role

• The Medical Director will lead medical strategy/activities on clinical late stage drug development projects (proof-of-concept up to registration).

Responsibilities:

• Define the medical strategy: Articulate a clinical programme, which will provide the data necessary for drug registration or WHO prequalification, as a member of a cross-functional project team
• Together with the team, deliver the agreed development plan within the timeframe and budget
• Coordinate and complete relevant sections of scientific and strategy documents, protocols, clinical study reports, the investigator's brochure and other regulatory documents
• Participate in interactions with regulatory authorities
• Manage drug safety: Acting as medical monitor, ensure clinical teams correctly handle all adverse events (AEs) and serious adverse events (SAEs), in accordance with ICH standards
• Be the main contact point for the Pharmacovigilance (PV) provider across studies
• Actively participate in project team meetings led by the project leader; organize and lead relevant sub-team meetings
• Communicate clinical results internally and externally and represent the Medical team at various congresses and events

Profile:

• Registered Medical Doctor (mandatory qualification)
• PhD would be an asset
• At least 7 to 10 years of experience of drug development in the pharmaceutical and/or biotech industry, covering post proof of concept stage of development and registration
• Clinical development experience in tropical and/or infectious diseases in developing countries
• Clinical development experience in paediatrics would be an asset

Votre contact

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La référence de cette offre est JN -092018-293685 - HAID

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