Experience

Blueprint Medicines

• United States
• Biotechnology Research
• 400 - 500 Employee

• Medical Lead France & BENELUX

  • Mar 2020 - Present

  Starting from scratch to build the Medical Plan/Budget (600KE) and Department (first employee in Europe) • Set up the Medical Affairs department and all Medical Affairs activities in France & BENELUX (CME, Ad Board, ISTs, Symposiums, congresses, Abstract submissions & Case report publication, KOL engagement plan, data dissemination, PAGs relationship…)• Proposed a strong Medical Affairs strategy in FRBNLX, fully aligned with Commercial Department’s expectations• Support Market Access & Pricing Lead in France & BENELUX…built specific projects (synthetic control arm in AdSM) for a better national HTA acceptance• Built an efficient “Precision Medicine Liaison” team with 4 peoples in France and 1 in NL to engage with Oncologists/Hematologists and Pathologists…to boost clinical study enrolment and build a strong relationship with HCPs• Support Clin Ops Team in all clinical studies and registry for a better patient delivery and for reducing start up timelines• Deployed successfully AP2 for AVAPRITINIB (Kit and PDGFRA inhibitor) in AdvSM patients• Responsible of cATU for AVAPRITINIB in PDGFRA D842V GIST patients• Deployed successfully cATU for PRALSETINIB (RET inhibitor) in NSCLC patients• Work closely with Clin Dev to set up study design that fit with French Health authorities’ expectations for P&R Show less

• Precision Medicine Liaison - France & Belgium

  • Sep 2018 - Mar 2020

  Support the full Blueprint Medicines portfolio in Belgium-France (AVAPRITINIB and PRALSETINIB):• Defined Medical Affairs strategy in FRBNLX • Responsible for developing excellent working relationships at the company’s trial sites, with oncologists and with pathology lab.• Managed IST/synthetic control arm in different field (GIST-Lung-Thyroid- Systemic Mastocytosis area).• Developed efficient collaboration with PAGs and oncology Networks (IFCT- GFPC – TUTHYREF-CEREMAST).• Created awareness with Oncology institutions (INCa - UNICANCER) and authorities (ANSM about ATU process). Show less



IGNYTA, Inc.

• Nantes Area, France

• Precision Medicine Liaison - Belgium/France/Switzerland

  • Oct 2016 - Aug 2018

  Support global phase 2 registration trial "STARTRK-2" in Belgium-France and Switzerland. Responsible for developing excellent working relationships at the company's trial sites, with oncologists, with pathology lab and the clinical trial site teams: - Develop and maintain key strategic relationships with investigators participating in STARTRK-2 study and develop strategic clinical relationships with physicians in this region. - Provide clinical support for all activities from site selection/initiation through closeout, making sure the sites are achieving the appropriate levels of enrollment and recruitment targets through active engagement with the Principal Investigators and site visits... - Supervised/Manage CRO mandated by Ignyta for clinical research activities (Start up and Monitoring). - Collaborate with internal and external stakeholders to ensure operational excellence for the Company’s study plans. - Establish and maintain strong working relationships with important thought leaders/KOLs/investigators/Networks/patient advocacy in the oncology medical and pathology field. - Provide insights into the competitive landscape from a local level. - Help to encourage, train, and trouble-shoot local IHC (immunohistochemistry) and NGS (Next Gen Sequencing) patient testing approaches. - Maintain current knowledge in oncology, the science, competition, key opportunities, etc Show less



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Site Network Manager

  • Apr 2015 - Sep 2016

  Work together with Quintiles project strategy and project teams to enhance the overall patient recruitment and site relationship efforts. Dedicated to securing site partnership and alliances to improve the experiences of our customers and the patients.- Ensure right sites are selected for assigned studies by collaborating with project strategy and project teams.- Focus and concentrates more projects into fewer sites through improved capabilities for enhanced recruitment performance.- Own and optimize project delivery accross portfolio of sites including linkage to th therapeutic requirements of the future.- Conduct accompanied site visit to guide CRAs/support CRAs- Manage/Mentor CRAs (line management).- Manage staff in accordance with organization's policies and applicable regulations.- Support process improvement through working with Quintiles processes to deliver quality and consistency in assigned geographic territory... Show less

• Strategic Site Relationship Manager - Quintiles

  • Jan 2012 - Mar 2015

  Accountable for delivering investigator site commitments throughout regional model by identifying, cultivating and selecting Partner sites and high performing sites that regularly support Quintiles current and future therapeutic portfolio. Responsible for building, managing and developing site relationships at strategic levels.- Provide leadership to ensure partner Sites meet or exceed customer expectations.- Ensure continuous improvement of processes applied by partner Sites to execute on trials. - Act as an representative and spokesperson for partner site to ensure mutual benefits- Manage the progress of specific legal documents outlining basic principles of the business relationship partner Site- Ensure GCP guidelines are enforced at the site and adequate SOPs are in place - Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner- Effectively promote the services provided by partner Sites to internal and external customers- Work together with Quintiles project teams to ensure sites are selected for assigned studies- Maintain regular communication with assigned sites on non-project issues such as business strategy, mutual pipelines/planning, performance trends across all studies and compliance with contracts- Accountable for site performance, on a qualitative and quantitative basis- Collaborate with key stakeholders to resolve issues providing recommendations for solutions- Recommend site strategy/recruitment options to internal project managers and clinical team leads- Extract and manage global site performances data from company systems- Assist in developing and implementing creative, mutually beneficial ways to conduct business with partner sites- Implement physician engagement initiatives to increase participation in research- Identify quality risks and issues and create appropriate corrective action plans. Show less

• Senior Clinical Research Associate - Quintiles

  • Jun 2010 - Jan 2012



University hospital of Brest

• Clinical Research Associate

  • Aug 2009 - Jun 2010

  Studies: - French, multicenter, randomized, double blinded, placebo controlled trial study phase III in Thrombosis disease (treatment, 374 patients, 17 centers) - French, multicenter, randomized, double blinded, placebo controlled trial study phase II in Rheumatology (treatment, 120 patients, 13 centers) - French, multicenter, randomized, comparative study phase III in Orthopaedic surgery (treatment, 64 patients, 13 centers) - French studies in Thrombosis, Emergency services and Anesthesia in Hospital of Brest - French, multicenter, randomized, comparative study phase III studies in Kidney transplant (treatment, 300 patients, 20 centers) Initiation, monitoring and close-out visits, investigators meeting; Contracts negotiations with investigators and hospitals directions; Motivation of investigators in order to achieve recruitment targets (Newsletter); Elaborating of detailed accurate and timely visit reports; Maintaining all files and documentation up to date (TMF-blinder); Communication and coordination on daily basis with the project manager; Extensive liaison with data management and statistics department to achieve data base lock; Study drug treatment management; Ensuring and following up of SAE; Input into protocol writing, CRF design and other study documents (inform consent and annual safety report); Pre-study activities and amendment: Ethics Committee submissions. Show less



CLINACT

• France
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Clinical Research Associate

  • Nov 2008 - Aug 2009

  Studies: - Global, multicenter, prospective study in Cardiovascular-diabetes (Medical device, 500 patients, 30 centers) - Global, multicenter, prospective study in Oncology (treatment, 210 patients, 21 centers) - French, multicenter, retrospective study in Neurology (treatment, 190 patients, 20 centers) - In charge of monitoring and reporting of quality control in French observational and prospective study in drug addiction (treatment, 1303 patients, 263 centers) Initiation, monitoring and close-out visits, investigators meeting; Contracts negotiations with investigators and hospitals directions; Motivation of investigators in order to achieve recruitment targets (Newsletter); Elaborating of detailed accurate and timely visit reports; Maintaining all files and documentation up to date (TMF-blinder); Communication and coordination on daily basis with the project manager; Extensive liaison with data management and statistics department to achieve data base lock; Study drug treatment management; Ensuring and following up of SAE; Input into protocol writing, CRF design and other study documents (inform consent and annual safety report); Pre-study activities and amendment: Ethics Committee submissions. Show less



New York Medical College

• United States
• Higher Education
• 700 & Above Employee

• Research Associate

  • Jan 2007 - May 2008

  “Effect of acute or chronic administration of aldosterone in microvascular reactivity in rat or mice””. SPECIFIC SKILLS - Research management: Setting up and following up of research plan, analysing data and statistic reports and communication of results to the principal investigators; Writing scientific publications; Supervising of students and technicians. - Laboratory techniques: Isolating, cannulating and pressurizing of microvessels (75 µm), Myograph, Laser Doppler, Echo-Doppler, Western Blotting, Spectrophotometric and fluorometric assay, RNA isolation, RT-PCR quantitative, Endothelial Cells culture, Isokinetic Ergometer, Electromyography. - Softwares: Utility programs (Word, Excel, Power point, Endnote, Photoshop, Slidewrite), Statistic (GraphPad Prism4, Statistica), Acquisition softwares (Perisoft, UN-SCAN IT gel, Image J, WinDaq, I.O.X., Acqknowledge, Cardlog). Show less



Nantes Université

• France
• Higher Education
• 700 & Above Employee

• Tenure track

  • Sep 2005 - Aug 2006

  laboratory of “Motivity, Interaction, Performance” JE 2438, University of Nantes, France. “Evaluation of blood flow during various modalities of dynamic contraction (isotonic and isokinetic): effect of the speed of contraction” SKILLS Brachial blood flow measurement by Ultrasound, Isokinetic Ergometer, Electromyography laboratory of “Motivity, Interaction, Performance” JE 2438, University of Nantes, France. “Evaluation of blood flow during various modalities of dynamic contraction (isotonic and isokinetic): effect of the speed of contraction” SKILLS Brachial blood flow measurement by Ultrasound, Isokinetic Ergometer, Electromyography



Université de Bretagne Occidentale

• France
• Higher Education
• 700 & Above Employee

• Tenure track

  • Sep 2004 - Aug 2005

  laboratory of Integrative and Comparative Physiology (EA 3879) University of Brest. “Effects of exercise training on muscarinic receptors in rat thoracic aorta”. laboratory of Integrative and Comparative Physiology (EA 3879) University of Brest. “Effects of exercise training on muscarinic receptors in rat thoracic aorta”.