Cyril Moulin Email & Phone Number

Nyon, Vaud, Switzerland

- Close collaboration with global Medical Affairs for scientific content and communication towards health care professionals.- Provide medical and clinical expertise in case of potential safety alert involving commercialized Edwards products to understand the nature of the issue reported and possible health risks associated and take appropriate actions.- Internal medical expertise surrounding Edwards products, scientific support to marketing and market access.- Medical expert for clinical studies: safety assessments of adverse events, participation in elaboration of CEC and DSMB/DMC charters, prepare or review event narratives for regulatory submissions, input into safety sections of study protocols

Geneva Area, Switzerland

- Responsible for developing scientific content from clinical trials and registries to ensure relevant communication with Health Care Professionals and Heath Authorities.- Implementation of clinical protocols and reports/data presentations and publications.- Safety oversight: - Management of a team of 3 safety officers. - Ensure all EU safety surveillance and monitoring, identification and reporting of adverse events and device-related complications are completed in accordance with regulatory and corporate/divisional requirements. Follow up with European/US Regulatory Affairs. - Management and Follow Up of DSMB and Clinical Evaluation Committees.

Sophia Antipolis

- Management of a team of 15 people (clinical project management, biostatistics, medical writing). - Development and management of Phase IV studies carried out in Europe, Asia, Australia, Canada and Latin America for Galderma products treating Acne, Onychomycosis, Non Melanoma Skin Cancers, Rosacea, Psoriasis, Atopic Dermatitis.- Drawing-up Life Cycle Management Plan in collaboration with Global Medical Affairs, Marketing and Regulatory Affairs. Support for Pharmacovigilance of registered products.- Build scientific and medical messages to support Marketing claims.

Sophia Antipolis, France

- Management and organization of the Scientific Affairs Direction, including 4 departments: Education, Guidelines, Registries and Publication (ESC Journals & textbooks). Total headcounts: 22 persons, including 4 Heads of Departments.- Development of high quality accredited CME programmes for cardiologists. Working relationships with UEMS, EBAC.- Successful implementation of a global programme of observational studies in Europe (launch of 10 long-term registries within 2 years).- Steering of European Key Opinion Leaders to help with scientific activities, such as the production of clinical practice guidelines (4 to 5 Guidelines produced each year).- Advocacy and fundraising for ESC Scientific Activities towards Pharma & Devices companies and other partners.

Lausanne, Vaud, Switzerland

Responsible for the clinical development of two JNK inhibitors, XG-102 and XG-104.Development Proof of Concept strategy with drug discovery team and external experts in several therapeutic areas, including inflammatory bowel diseases, rheumatoid arthritis and ophthalmology (uveitis, AMD). Experience in animal models and expertise in the use of biomarkers for drug development.Participation in regulatory strategy and validation of development program with regulatory authorities.Phase 1 and phase 2a studies: preparation of core clinical trial protocols together with statisticians and data managers (CROs).

Drug Discovery and Clinical Research (phase I and IIa). Drug development in several therapeutics areas, including Inflammatory Bowel Diseases, Rheumatoid Arthritis and ophthalmology (uveitis, AMD)

- Clinical Research Director:Responsible for the Clinical Development of a new drug in thrombosis. Coordination of phase 1 studies (Single and multiple rising dose studies, drug-drug interaction studies…).Contact external experts to implement development plan and core trial protocols- International project leader and protocol author for a phase 3 study for the registration of a new oral anticoagulant in venous thrombosis. Scope of Study: 250 centres worldwide, 2000 patients. Pilot of Study as well as of various international study committees (Steering Committee, DSMB) and CROs.

- Management and organization of the Clinical Research Unit including coaching and training of CRU staff (3 Project leaders and 3 assistants) and sub-contractors - Implementation of 14 international clinical trials in France (from phase 1 to phase 3 studies) according to local and international regulatory and quality standards. Monitoring of trial progress as compared to forecasts. International development of 3 major products in cardiology (an oral anticoagulant (DTI), a fibrinolytic and an antihypertensive drug and one major product in type 2 diabetes (DPP IV inhibitor).

Achieved Clinical Studies- Project Leader and Protocol Author for a successful comparative study in hypertension (Phase IV study, (Irbesartan/HCTZ vs Valsartan/HCTZ). Scope of study: 140 centres (GP network), 800 patients;- Regional Project Leader for three large morbi-mortality trials, in chronic heart failure (Overture Study, omapatrilat), in heart failure with preserved systolic function (I-Preserve, irbesartan) and in atrial fibrillation (Active Study, clopidogrel).Marketing support- Active team member for providing medical expertise and industry knowledge of two major products in CardioVascular disease, i.e. Irbesartan and Clopidogrel (phase IV studies, educational presentations to specialist doctors, symposia...).- Managed the pre-clinical research grant for the development of a new drug (omapatrilat) for hypertension and heart failure. Increased pre-launch awareness of the drug across France.

-Project leader for 2 phase IV studies involving 800 cardiologists, 100 GPs and 2500 patients: protocol author, co-ordination, follow-up and submission of results evaluation report;-Project leader for an epidemiological cardiovascular study involving 800 cardiologists and 2500 patients: protocol author, creation of Steering Committee;-Launched a hypertensive drug (telmisartan), and post-launch Marketing Support.

Post Graduate Diploma In Cardiovascular Prevention And Rehabilitation

Post Graduate Diploma In Sport'S Cardiology

Md, Board Certified Cardiologist

Activities and Societies: Internal Medicine, Critical Care and Cardiology

Master Degree, Cardiovascular Pharmacology

Post Graduate Diploma Of Medical Statistics (Cesam)

Medicine