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    Associate Director or Director - United Kingdom - Incyte Corporation

    Incyte Corporation
    Incyte Corporation United Kingdom

    1 week ago

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    Description

    The UK&I Associate Director/ Director Clinical Operations is the local Clinical Operations tactical expert responsible to provide leadership and local strategic oversight of the Incyte pipeline, provide adequate planning and operational delivery of assigned clinical trials, in accordance with the appropriate quality standards, including ICH/GCP/GPP standards, Incyte SOPs, local operating guidelines and local requirements, as applicable.


    Duties include but are not limited to:
    (1) direct/indirect management and support of country clinical operations staff including resource assignment, development, training, and performance review (2) oversight of Programs/clinical trials assigned to ensure UK&I implementation and progress (3) a key partner with Development Operations (e.g Asset Lead and CTMs), Regional Clinical Operations (ReCO), UK&I Senior Management, Medical affairs and other Development Operations senior management stakeholders, as required, in all aspects of drug development strategy and management.
    Is responsible for the planning, execution and oversight of development operations activities in UK&I
    Asset Leads, Global Clinical Trial Managers...) and countries (eg. Medical Affairs, Market Access, General Manager...) Asset Leads, Global Clinical Trial Managers...) to support the timely and efficient set-up and maintenance of outsourced and internal clinical trials in UK&I
    Demonstrate ability in working in a matrix organization by partnering with UK&I organization, EU Medical Affairs, Regional Clinical Operations (ReCO), Development Operations and Clinical Development to identify investigators, clinical experts, cooperative groups, build local network, that support pipeline development in all therapeutic areas
    Communicate and update on regular basis on local clinical Trial activities and strategy with the UK&I organization (eg. General Manager, Medical Affairs, Market Access...) and Development Operations (eg.
    Asset Leads, Global Clinical Trial Manager, Senior Management...)
    Track country KPI (e.g. country enrolment target), to ensure high performance and implement corrective actions as needed
    Provide inputs and contribute to the improvement of Development Operations SOPs and processes (Global, Regional and local level)
    Identify gaps and lead and implement local SOPs, WIs and processes in collaboration with other departments as needed
    Perform other duties as assigned by Development Operations management (local/Global level)
    Manage local clinical operations resources based on UK&I activities and engagement (current and future pipeline development).
    Hire local clinical operations team members with support from functional management as needed (eg. Monitoring, Study Support...)
    Conduct performance reviews of direct reports with support as needed. Oversee proper handover and training documentation for internal monitoring activities
    Medical Affairs, monitoring, HR ...)
    Minimum Bachelor of Science degree or equivalent degree

    Minimum of 5-7 years (Associate Director) or 7-9 years (Director) experience working in clinical operations within the biopharmaceutical industries and/or Clinical Research Organization ('CRO'), including at least 3 years (Associate Director) or 5 years (Director) in a role of primary responsibility for clinical trial execution and management.

    Operational and direct managerial experience in the planning, executing and reporting of clinical trials
    Good knowledge of GCP, clinical trial design, statistics, regulatory processes, inspection readiness and drug development process
    Goal oriented, self-starter with proven ability to work independently in accordance with stated timelines and quality
    Must be able to travel (domestic and international) up to 10%
    Management reserves the right to change or modify such duties as required.

    The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

    You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data.

    You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

    You can learn more about Incyte's data protection practices here .

    By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).

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