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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, Company could provide you the perfect opportunity.
Leads the clinical development strategy and over sees 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.
*Day to day management and support of Global Development Team Members
*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.
*Defines protocol outlines.
*Ensure s/he is knowledgeable about both clinical safety and efficacy aspects of the product under development and seek internal or external advice as appropriate.
*Review 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 (eg. 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 Company as the project clinical expert in regulatory agency meetings.
*Participate in the selection of CROs for clinical studies.
*Full Medical Doctor Qualification from recognised institution
*Board Certification in Dermatology or significant experience in this TA
*Alternative specialisation in Immunology or Internal Medicine will suffice if accompanied by significant clinical and/or industry exposure to Dermatology TA
*Minimum 5 years in core Clinical Research and Development
*Experience in Pharmaceutical company or CRO organisation in relevant function (Clinical Development Physician)