Experience

Banook Group

• France
• Hospitals and Health Care
• 1 - 100 Employee

• Clinical Study Management Lead

  • Sep 2020 - Present

  Overall responsibility of Study Management for all services provided by Banook Group in clinical trials: Cardiac Safety, Central Imaging, Endpoint Adjudication and eCOA solution - in all therapeutic areas from phases I to III (cardiovascular, dermatology, pulmonary/respiratory, metabolic diseases, oncology, inflammatory disease, neurology...) - working with Pharmaceutical companies, CRO, non profit organizations, Biotechnology companies.Overseeing and supporting an international team of clinical study managers based in France, Germany and Canada. Show less

• Clinical Project Manager - Cardiac safety

  • Jun 2013 - Aug 2020

  Management of ECG central reading activities (cardiac safety, TQT, SAD/MAD studies) in all therapeutic areas from phases I to III (cardiovascular, dermatology, pulmonary/respiratory, metabolic diseases,...), working with Pharmaceutical companies, CRO, non profit organizations, Biotechnology companies.



Genclis SAS

• France
• Biotechnology Research
• 1 - 100 Employee

• Cancer Test Development Manager

  • May 2011 - May 2013



Bio-Rad Laboratories

• United States
• Biotechnology Research
• 700 & Above Employee

• Business Unit Project Manager

  • Oct 2008 - Apr 2011

  • Project Management for the virology and cardiology products developped on the BioPlex™2200 immunoanalyzer• Set up and follow the project schedule, ressource and budget• Built the project Design History File, reviewed deliverables prepared by team members• Set up regular project reviews with core teams and stakeholders (France, US) • Coordination with transversal teams in France and US: R&D, system integration, marketing, production (US), regulatory and clinical affairs,quality assurance Show less

• R&D Group Manager - Cardiovascular Business Unit

  • Nov 2003 - Sep 2008

  • Responsible for the development of a cardiovascular menu on a new high throughput immunoanalyzer, the BioPlex™2200• Managed a team of 13 people• Assisted in annual budget preparation and R&D portfolio management• Initiated and supervised the R&D projects in an international (mainly US) and multidisciplinary environment (chemistry, intrumentation, software)• Coordination with transversal teams in France and US: research, development, system integration, marketing, production (US), legal, regulatory and clinical affairs,quality assurance• Patent portfolio management• Managed R&D collaborations to assess new technology or biomarker, and with clinicians to set up clinical trials• Patent filing, publications and communication in international congress Show less



Bio-Rad Laboratories

• United States
• Biotechnology Research
• 700 & Above Employee

• R&D Project Leader - Cardiovascular

  • 2000 - 2003

  • Responsible for the cardiovascular research projects • Developped a new method to measure the B-type natriuretic peptide precursor (proBNP) to diagnose congestive heart failure • Developped monoclonal antibodies and recombinant proteins • Filed a patent of major interest on this biomarker • Set up collaborations with clinicians to validate the biomarker • Responsible for the cardiovascular research projects • Developped a new method to measure the B-type natriuretic peptide precursor (proBNP) to diagnose congestive heart failure • Developped monoclonal antibodies and recombinant proteins • Filed a patent of major interest on this biomarker • Set up collaborations with clinicians to validate the biomarker



Sanofi diagnostics Pasteur

• Mions (69) France

• Project leader

  • 1998 - 1999

  • Developped cardiac marker assays in manual format and on an immuno-analyzer (Access®) for the diagnosis of myocardial infarction • Performed feasibility study on a Point of Care Technology • Set up and follow up of the clinical trials for product registration • Patent filing, publications and communication in international congress • Developped cardiac marker assays in manual format and on an immuno-analyzer (Access®) for the diagnosis of myocardial infarction • Performed feasibility study on a Point of Care Technology • Set up and follow up of the clinical trials for product registration • Patent filing, publications and communication in international congress