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Summary

Highly experienced, motivated and charismatic leader with 25+ years of in-depth experience in the CRO industry and the pharmaceutical environnment.Twenty years of management experience and track records managing multiple projects/teams to ensure optimal quality, achieve company goals and surpass client expectations.Top level oversight of clinical operation services across multiple countries, country and project management as well as customer partnership development.Regional Line management role leading up to 350 employees in a global environment with a special focus on Europe. Range of expertise from early stage to late phase international Clinical trials, Start up, Regulatory, Monitoring, Quality control, Budgeting and P&L responsibility. Specialties :Clinical Operations Management; General Management; Leadership & Teambuilding; Project Management; Building Professional Relationships; Staff Development and Mentoring; Talent Management;Vendor Relationship Management; Corporate Strategy; Multicultural Awareness; Risk Analysis; Business Development, Proposals and Customer meetings; Change Management; Europe; Strategic Thinking;Merger & acquisitions;

Experiences

Current Experience

  • Regional Director -Clinical Operations -across european countries
    Since September 2011
    *Sets overall direction , strategy and performance standards for Clinical Operations across diverse countries to assure that project profitability targets are achieved *Accurately projects resource needs to ensure timely hiring and adjustment of resource allocation to projects to meet client's objectives *Schedules and reviews project tasks to ensure high quality product is delivered on time and within budget *Serves as liaison between Clinical Operations and Project Management or other internal departments to maximise co-operation and co-ordination as required by projects *Act as a point of escalation to ensure optimal project delivery *Ensures services provided to clients are compliant with PRA's policies , procedures , SOPs , ICH-GCPs , client contractual expectations and country regulatory requirements *Provides input to proposals and guidance on aspects of clinical operations and identification of risk and budgetary implications *Participates in client's presentations or bid defense meetings as required *Provides ledearship of regional team , mentoring for regional management team and develops employees to expand individuals' perfomance levels and assure retention of high performing employees. *Led Regional or EAPA initiatives for enhancing quality and improving system/processes

Past Experience

  • Global Operational Lead
    November 2009 --- September 2011
    *Management of a global program for strategic clinical resourcing , member of the Large Scale Functional Resourcing group *Accountable for setting up all operational processes, systems and communication lines between CRO and sponsor for an hybrid model across 28 countries ( Europe , South America , Asia and Australia) *Responsible for the overall clinical trials conduct and acts as a point of escalation to ensure optimal client delivery *Functional line management of project teams and country line managers *Direct line management of the global trainer, quality manager and transitional lead *Coordinating business support functions for the model: HR, IT and finance *Managing third party vendor: Supply chain management *Model and project revenue recognition and invoicing *Leading monthly operational governance meetings with sponsor and attending quarterly strategic steering committee meetings

  • Senior Director Clinical Operations - France & Belgium
    January 2000 --- November 2009
    *Responsible for Paris and Strasbourg clinical teams to maintain a sustainable growth up to 240 heads. Management of Roche Oncology operational team integration in Strasbourg *From Sept 2007 to May 2008, managing Belgium Clinical Operations in addition (60 heads) *Line management and project delivery, high staff retention, cultural exposure & awareness *Implementation of a new business model for 3 sponsors

  • Associate director -Clinical operations and Office leader
    April 1991 --- June 1998
    *Setting-up of the French office of an English CRO- expanding a team from 2 to 15 employees and responsible for the overall team and project management *Overseeing and managing administrative tasks , facilities , HR , Recruiting , clinical budget and P&L within geographical area *Operational management and monitoring in France of worldwide clinical trials (phases II/III/IV) in cardiology, antibiotics, virology, renal insufficiency/kidney transplant *Local customer relationship developments

  • Senior CRA-Clinical team lead
    January 1990 --- January 1990
    Lead CRA , coordinating monitoring activities of the french CRA team

  • Clinical Research Associate (CRA)
    January 1988 --- January 1990
    *French monitoring of clinical trials (phases II, III, IV) in cardiology, psychiatry and gynaecology

  • Regulatory Affairs Specialist
    January 1988 --- June 1988
    *Trainee in the regulatory department *Participation to a submission dossier for a new drug registration .

Knowledge

LinkedIn Assessment :
CROClinical researchClinical trialsClinical DevelopmentClinical operationsClinical monitoringICH-GCPPharmaceutical IndustryRegulatory submissionsTeam LeadershipPeople DevelopmentInternational DevelopmentSite InspectionsTeam ManagementCross-functional team leadershipHiringRecruitingResource ManagementProject ReviewsoncologyRegulatory affairsGCPCTMSOperations Management

Education

  • DESS heath & medicines laws & regulations in from Univeristy Paris IX in 1988
  • PHD Pharmacy in from University Paris V Pharmacy in 1988
  • in from Lycée Condorcet in 0

Area / Region

Paris, France

Others

Driving License
  • Yes