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Snr. Clinical Leader will have a wide scope of responsibilities covering leading on the clinical development strategy and overseeing operations of clinical development team for the project(s) assigned. Lead and develop Clinical Leads and Scientist responsible for the corresponding project.
Responsibilities will include:
*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
*Clinical Specialisation in Dermatology, Immunology or Internal Medicine will be desirable and/or industry exposure to Dermatology TA
*Minimum 10 years in core Clinical Research and Development
*Experience in Pharmaceutical company or CRO organisation in relevant function (Medical Director; Clinical Development Lead/Physician)
*Line Management experience
*Excellent knowledge of Dermatology
*Strong knowledge of clinical development methodology.
*Deep understanding of the scientific and biostatistical data.
*Proven ability to provide strategic and medical oversight to phases I, II, III of global clinical trials.
*Leadership and team work.
*High presentation skills
*Strong verbal and written communication in English is must
*Ability to provide functional leadership is must
*Team and group leadership and management