Clinical Data Transparency Clinical Trials Logistic Data and Tech Driven Clinical Trials Patient Centricity
Health Literacy Labeling Regulatory Affairs R&D Operations Finance Management
Senior Manager/Director with 10+ years of project management leadership and entrepreneurship in Regulatory affairs, Clinical trials and Health Literacy.
Relocated from France to USA as the trailing spouse in February 2018.
High potential with aspiration, ability, and engagement. Experienced in all aspect of business formation, R&D operation, finance and management.
Exceptional abilities to identify company needs with a patient-centered approach and to manage projects from scratch to success. Entrepreneurial mindset and relentless optimist who seeks new challenges.
SERVIER LABORATORIES R&D 07/2016 - 01/2018 FRANCE
Clinical Data Transparency, Senior Project Manager
Developed New Transparency Policy and wrote new Stand Operating Procedures regarding access to clinical data upon request, clinical study results publication and clinical study reports.
Led update of new clinical transparency website (clinicaltrials.servier.com). Wrote content, chosen design, monitored professional services to develop Data Request Portal.
Benchmarked EFPIA/PhRMA data sharing principles, EMA Policy 70, EU Clinical Trials Regulation and FDAAA 801 requirements. Submitted recommendations and budget to fill gap with competitors and reach top 5 of Alltrials Transparency Ranking. Obtained full approval from board of directors.
Developed a flagship project from scratch and led all organizational operations to implement 99 provisions of New European Clinical Trials Regulation. Led 12 working groups (EU Portal, Transparency Policy, Safety Portal, Informed Consent in minor, Urgent Safety Measures, Serious Breach, Personal Data Protection Participated in EMA UATs.
Organized trainings with all R&D directorates to test future EU Clinical Trials Portal. 50 participants involved, on voluntary basis, in training sessions.
Monitored all public registries (EudraCT, clinicaltrials.gov, ISRCTN) and instilled strong focus in teams and partners on consistency of trial/product information across disclosures and associated areas such as Clinical reports anonymization, publications and data-sharing.
Responded to non-profit organization and academic researchers requests regarding clinical data transparency (Alltrials, Trialstracker, Good Pharma Scorecard, Stat news).
Represented Clinical Studies Department in Working groups regarding eConsent, eProtocol, Investigator Brochure, Clinical Study Report, New Regulation on Data Privacy. Organized and led a hackathon to show the eProtocol’s proof of concept.
Led patient centricity approach regarding the informed consent form and the lay summary with the involvement of Patients Association in our processes.
TIM 04/2012 - 06/2016 FRANCE
Created patient-centered activities to avoid medication errors by improving Labeling (packages and leaflets), by testing usability of medical devices.
Developed new Patient Education tools: Patient diary, Website, User guide in Risk Evaluation and Mitigation Strategy.
Devised analyses, training and SOP to respond to the new French Sunshine Act.
Delivered regulatory information and practical cases via a Blog, Twitter and Facebook page.
Uncovered new clients and business opportunities. Reached annual turnover of 120k Euros.
LNA 02/2006 - 04/2012 FRANCE, UNITED KINGDOM
Launched new activity: The Readability User Testing (informed consent, patient leaflets, patients guides).
Directed and developed business in France and UK. Recruited 10,000 people in France and 2,000 in UK for consumer panel to test and improve readability of patient leaflets and documents. Managed up to 10 employees.
Over 100 clients (Sanofi, Pfizer, GSK, Merck, Teva). Reached average annual turnover of 1.70MM Euros.
Led awareness campaign with French Parliament to sped-up transposition of European Directive into national law.
Organized training 2 conferences with French Health agency.
SANOFI-AVENTIS 07/2005 - 01/2006 FRANCE
EU Regulatory Intelligence Manager
Monitored and provided integrated analyses and advice on new EU procedures, legislation/guidelines and on emerging regulatory and legislative issues affecting Sanofi (patent, bolar provision, life cycle management, registration, labelling, clinical trials, medical devices, data protection, paediatric regulations, etc…)
Prepared and coordinated Sanofi responses to EU draft guidelines and EU legislation
Established excellent communications with the pharmaceutical industry trade associations and regulatory agencies
Wrote recommendations regarding national and international regulations on counterfeiting (Mercosur, Russia, OCDE…)
PharmD, Pharmacy 1999-2005 University of Paris Sud France
MS, Pharmaceuticals Legislation, Health Economics and Management 2005 University of Paris Sud France
AA, Law 2002-2006 Sorbonne Law School (Distance Education) France
LANGUAGES AND SKILLS
Advanced English, French native speaker
Excellent command of processing packages: Microsoft Office (Word, Excel, Access, PowerPoint, SharePoint), Box, Adobe CS Creative Suite, understanding of XML Languages, WordPress, Social Media tools (Facebook, Linkedin, Twitter)
Deep technical background with experience using project management and user interface software.
Lecturer, Master in Biotechnologies Management 2006-2015 IONIS School France
Saxophone, Traveling, Swimming, Basketball