Axepta SA Global Clinical Operations Program Head Envoyer

My client is an innovating, dynamic and niche growing international pharmaceutical company currently expanding their clinical trial team based in Lausanne area.

Due to this growth my client is looking for a Global Clinical Operations Program Head to manage all clinical activities for several programs at a global level (including US, Europe or Asia) and to lead a team of Clinical Trial Managers and Leads.

Global Clinical Operations Program Head

Responsibilities:

• Lead and manage a team of Clinical Trial Leads, ensuring smooth completion of studies as per plans, plan resources, recruit talent, establish meaningful development plans, address performance issues and ensure proper issue resolution as appropriate;
• Lead and manage multiple clinical programs through the direct supervision of Clinical Operations Leads / CTLs, and in close collaboration with R&D cross-functional teams, ensuring smooth execution of studies (including budget and contracts review);
• Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, for all activities assigned.
• Establish solid external providers CROs/Vendors selection and oversight, as well as preferred supplier strategy;
• Improve Clinical Operations processes when needed, identify issues and propose solutions and action plans to be implemented by his/her team or by the extended Clinical Operations team, when appropriate, support functional initiatives and processes managed by Clinical Operations Department;
• Provide direction for the development of operational plans including enrollment models and risk management plans, financial planning and management, communication plans, and monitoring plans in collaboration with CRO, be accountable for inspection readiness;
• Be accountable for the review and expert clinical operations input into clinical documents related to the drug development process;
• Attend and represent Clinical Operations department in some of the Management Meetings;
• Design, review and approve of all trial related documentation, and establish trial processes;

Profil:

• PhD/University degree or equivalent in Life Sciences with at least 6 years' experience on Phase I-III international clinical trials management in Oncology.
• Demonstrated excellence in leadership and project/program management;
• Deep knowledge and experience on the implementation and use of EDC, IWRS, eTMF, CTMS and any other digital clinical trial systems;
• Solid experience in management of CROs, vendors and consultants, experience in external audits, an asset;
• Strong project management skills, excellent budgeting, planning, and communication skills;
• Fluent in English (French and another European language are an asset);
• Ability to travel according to business needs (10-20%).

For more information, please feel free to contact Morgane CAYUELA at morgane.cayuela@axepta.com