Global Clinical Leader - R&D Center - Spain

Select how often (in days) to receive an alert :

Global Clinical Leader - R&D Center - Spain

If you are looking to further your professional career in an innovative sector, as part of a highly qualified team where collective talent comes together, Almirall could provide you the perfect opportunity.

Mission

Leads the clinical development strategy and oversees operations of clinical development for the project(s) assigned. Leads the medical sub team for the corresponding project.

Tasks and Responsibilities

• Defines the objectives, strategy, milestones and resources required for clinical development, at least up to registration in line with the TPP and Target Product claims.
• Permanent member of the Project Core Team, representing Global Clinical Development.
• Leads / chairs the Medical Sub Team (MST).
• Provides guidance to Clinical Study Teams to ensure alignment of clinical trials planning and conduct with the overall development strategy.
• Ensures knowledge about both clinical safety and efficacy aspects of the product under development and seeks internal or external advice as appropriate.
• Reviews and approves (when applicable) key clinical trial documents (e.g. protocol, SAP, CSR).
• Responsible for clinical content for key internal or external project related documents (e.g. IB, briefing package for regulatory authorities, ISE, ISS, publication).
• Identifies and manages the Clinical risks and opportunities.
• Primary contact for Global Marketing & Medical Affairs to define the Market Access needs and clinical differentiation strategy.
• Represents Almirall as the project clinical expert in regulatory agency meetings.
• Participates in the selection of CROs for clinical studies.

Education

Skills

Values

If you are interested in this job offer, please apply below. In Almirall we are committed to diversity by recognizing talent and providing opportunities for all employees present across Europe, as well as in the US.

#J-18808-Ljbffr