Proclinical are representing a medium sized, global biotech who are expanding rapidly due the significant assets that are in development in their pipeline. As a result, they're seeking a Director of Clinical Operations Programs to strengthen their Global Clinical Trial and Program Operations team who can work remotely in Switzerland. The successful candidate must be based in Switzerland currently to be considered for this opportunity.
The Director, Clinical Operations Programs is responsible for the strategizing, planning, leading and execution of the operational path for all indications within a franchise from first in human studies through authorization and commercialization.
Please note that to be considered for this role you must have the right to work in this location.
Responsibilities:
1. Oversee Clinical Trial Managers (3-6 at one time)
2. Provide strategic input and are accountable for all clinical-related aspects within the assigned therapeutic indication/program.
3. Act as a senior point of contact for all clinical-related activities for a given Franchise across asset indications.
4. Oversee the resource requirements for Trial Operations within the franchise and ensure the needed resources are onboarded timely and efficiently.
5. Creates the clinical development plan in collaboration with the Medical Development Lead, PM and other clinical representatives, ensures the clinical development plan describes the clinical development strategy, comprising effective and where possible innovative trial designs.
Key Skills and Requirements:
6. Bachelor's or University degree in Biology, Biomedical Sciences, Pharmacy, Veterinary etc. or equivalent by experience.
7. PhD degree is an advantage.
8. Proven working history in Clinical Development (monitoring, local and global/international trial management).
9. Experience in working in an outsourced model, including overseeing CROs and vendors.
10. Rare disease and/or auto-immune clinical trial background is a plus.
11. Proven track record in relevant leadership positions, including line management, within Clinical Operations in the pharmaceutical/biotech industries