Strategic oversight, leadership and management across projects and study management staff. Partnering with key stakeholders to create and drive portfolio clinical operations strategy, execute clinical trials per timelines and budget, support global regulatory submission and life-cycle programs. Management of people from Clinical Trial Manager through Director level. Provide strategic input on organizational design, resourcing and overall departmental vision.

Line Management of 10 Study Managers and 6 Clinical Trial Associates taking care of 13 global studies (phase II to phase III registration trials) Responsibilities include:- Overall strategic management for the planning, execution and reporting of clinical trials needed to support INDs, sNDA, NDAs.- Interaction with study teams to ensure consistent performance and quality of work- Resourcing with cross-functional input- Strategic assessment of metrics and implementation of measures accordingly to support projects deliverables and targets- Represent Clinical Operations on the Solid Tumor and MDS/AML Clinical Development and project Team- Review of protocols and provide indication specific and operational guidance- Participate in vendor selection and quarterly CRO review meetings- Identify new process opportunities, drive and support process improvement initiatives, pressure test the implemented new processes- Support the planning and oversee the management of study budgets- Oversee vendors and site contracts, change orders- Oversee budget and resourcing tracking. Participate in head count planning- Assess performance of direct reports. Provide salary reviews and recommendation for promotion- Provide study/project specific mentoring- Oversee training and documentation requirements of direct reports. Assess the need of development of company sponsored training programs per function- Support recruitment of staff

Study Management of a Global Phase III Trial in Multiple Myeloma. Responsibilities include planning and implementation of all operational aspect of the clinical study, review of all study documents (e.g. protocol, CRF, ICF, study plans, etc), investigator selection and site management, prepare, negotiate, track study budget, assist in CROs/vendor selection, oversee and manage CROs/vendors, primary interface with all project team members, provide active input to SOP development.

Line management of a team of 7 Trial Managers and 2 Trial Assistants taking care of 43 global studies (sanofi-aventis sponsored, investigator sponsored, or sponsored by other Pharmas) in 7 indications with Taxotere®, Eloxatin® and Fasturtec® corresponding to a yearly budget of around 14 millions €. Responsibilities of the team extends from protocol development to clinical study report, and comprises CRO selection and management, organization of global investigator and monitor meetings, organization and participation in Steering and Data Monitoring Committee meetings, includes budget follow-up and reporting.Leader or member of transversal working groups in order to elaborate Clinical Operations SOPs.Assess performance and development needs of direct reports. Provide salary reviews and recommendation for promotion.

Management and coordination of up to 12 local and global, R&D and post-marketing studies in breast and ovarian cancer. Responsibility extends from writing of study protocols (both French and international) to Clinical Study Report and includes local regulatory submissions, centers’ selection, CRA coordination, coordination of Affiliates, CRF design and Data Management Plan validation.Member of SOP committee: global and local SOP review.