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CK Group
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Hatfield, Hertfordshire
Director, Early Phase Oncology Clinical Operations
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Job Type: Full-time |
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Overview
CK Clinical are recruiting for a permanent Director, Early Phase Clinical Oncology Operations to join a leading global pharmaceutical company. The position will be based in their offices in Hertfordshire. The Role: Providing oversight for a portfolio of early phase (I/Ib/II) clinical trials in the oncology team. Their lead oncology product is an effective treatment for a range of cancers, and is projected to be one of the most profitable and patent impactful products within the next few years. They are now undergoing early stage clinical trials for a range of indications. Accountability for the planning and delivery of a range of oncology studies, including CRO/vendor oversight, quality, safety and risk management, budget and resource allocation. Responsible for line managing the Clinical Operations team, including the Clinical Operations Leads (in both UK and US) and working closely with partners in order to help deliver oncology projects within agreed development milestone targets. Main Responsibilities: - Provide technical expertise to lead teams and complex studies within the Clinical Operations group. - Setting and achieving key milestones and projects within the Oncology teams, and working closely with CROs, project teams and departments to ensure that these objectives are met. - Line and matrix management of a Clinical Operations team both in the UK and US, collaborating with colleagues to ensure project deliverables are achieved. - Support delivery of Clinical Operations strategies, and identifying gaps and implementing new approaches and processes/systems which will benefit the business. - Ensure adherence to GCP guidelines, local regulatory requirements and SOPs. - Identify gaps in training and recommending solutions. - Manage team members, including professional development and performance management. - Act as mentor to study teams and more junior members of staff. - Support/review third party (vendors, contractors, consultants) work, approving invoices and resolving issues when necessary. Your Background: - BS/MS in relevant field. - Industry experience in Clinical Operations processes. - Previous line management experience. - Thorough understanding of current ICH/GCP guidelines. - Previous Oncology experience - early phase experience desirable. For more information or to apply for this Director position, please contact CK Group, quoting job ref 46594. It is essential that applicants hold entitlement to work in the UK.