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.
Responsibilities
- Is responsible for the planning, execution and oversight of development operations activities in UK&I
- Collaborate with Development Operations (eg. Asset Leads, Global Clinical Trial Managers…) and countries (eg. Medical Affairs, Market Access, General Manager…) to ensure continuous alignment on country strategy, execution, follow-up and support for outsourced and internal clinical trials
- Act as the country Clinical Operations expert/point of contact for the Development Operations (eg. 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
- Represent the country within the Regional Clinical Operations (ReCO), active leadership in conducting initiatives, workstreams as well as strategically position the respective country in the context of Incyte pipeline development.
- Represent Incyte externally and build relationships, including master agreements when possible, with key research institutions and investigators
- 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…)
- Assure country inspection readiness by developing country work instructions, procedures, SOPs, as needed and applicable by liaising with the respective relevant functions (e.g. Clinical QA).
- 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
- Implement individual development plan of direct reports with support as needed (eg. Medical Affairs, monitoring, HR …)
- Identify and organize trainings for UK&I clinical operations members or individual as needed
Requirements
- 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
- Must have experience in appropriate therapeutic area; preference in one or more of the following: Oncology, Dermatology and Immunology
- Proven ability to manage multiple tasks simultaneously and to lead a multi-disciplinary teams
- Proven ability to work in a matrix organization.
- Experience in developing effective relationships with key investigators
- Good knowledge of GCP, clinical trial design, statistics, regulatory processes, inspection readiness and drug development process
- Excellent organisational, problem-solving, and written/verbal communication skills
- 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%
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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