Clinical Operation Lead - Mechelen, Leiden
Ref: MEC 229
You will support the Development Project Team in contributing to the clinical evaluation of new drug candidates through strategic input and operational excellence in management of multinational clinical studies from phase I till MAA/NDA.
In particular, you will:
- Act as the Clinical Operation Lead for all studies in the project. Providing support and leading the Clinical Study Leads to ensure delivery of each study within agreed timelines, budget and high quality.
- Act as Clinical Study Lead in early stages of the project and operationally set-up phase I studies in vendor CPUs, overseeing conduct & close-out.
- Responsible for budget and timeline forecasting, reporting and oversight on a compound level
- Provide input on Clinical Development Strategies from the selection of a Pre-Clinical Candidate up to MAA/NDA
- Closely collaborate with the Medical Lead on defining the Clinical Development Strategies, including the assessment of the required studies and their design
- Co-share Clinical Working Groups (with Medical Lead), overseeing the overall clinical development plan and operational management thereof.
- Be an active member of the Project Team Meetings
- Set-up scientific advisory boards and build and maintain a network of Key Opinion Leaders
- Review Clinical Study Protocols, Clinical Study Reports, Statistical Analysis Plans, Mock Tables, Listings and Figures, DSMB charters and ensure consistency across all the studies within your compound development
- Review IBs, including Risk/Benefit ratios and its implementation in all applicable study-related documents
- Initiate and/or participate in Process Improvement initiatives.
- Act as Line Manager for the Clinical Study Leads within the project
The successful candidate:
- is a Master or a PhD in life sciences and at least 7 years of project management experience in (Phase I, II and/or III) clinical drug development.
- has experience in operationally coordinating study set-up, conduct and close-out and vendor management.
- has experience in setting-up Clinical Development strategies from early stages (is a plus).
- enjoys working in cross functional teams
- has excellent oral and written communication skills especially in English (writing and speaking).
The selected candidate has strong organizational skills, is result-driven and pro-active and is able to travel.