Stephane Dubois

For Hypertension and Dyslipidemia, within Cardiometabolism and Veinous diseases therapeutic area - Lead global evidence generation team - Responsible/Accountable for evidence generation strategy to feed medical communication and promotional material with new data in line with global strategy for cardiometabolism - TAE and scientific society engagement in evidence generation project - Oversight of evidence generation project from conception to delivery (publication) - Strategy of communication of new data through omnichannel program

- Lead and manage Global Evidence Generation manger team for hypertension and dyslipidemia (cardio metabolism and veinous disease unit) - Lead clinical studies (phase IIIb and IV) and Global Evidence Generation projects to support Lyfe Cycle Management of drugs (scientific communication, promotion...) - Ensure that clinical studies & evidence generation related projects are carried out at the international or national level, in accordance with internal procedures, technical protocol, and time and budget targets. and in line with global marketing and affiliates expectations. - Design and follow studies 3b and 4, registers, generation and analysis of data. - Interact with the subsidiaries and in consultation with the medical business team

To set up clinical studies (phase IIIb and IV) and data generation projects to support Lyfe Cycle Management of drugs (scientific communication, promotion...) Ensure that clinical studies & data generation related projects are carried out at the international or national level, in accordance with internal procedures, technical protocol, and time and budget targets. and in line with global marketing and affiliates expectations. - Design and follow studies 3b and 4, registers, generation and analysis of data. - Interact with the subsidiaries and in consultation with the medical business team

phase II study in Knee osteoarthirtis - ensure implementation and follow up of clinical studies at the operational level in compliance with accepted constraints of quality, time and budget. - Functional leader of local responsible of studies. - Reporting to hierarchy with operational feedback - Responsible of feasibility studies (lead process and analyses of the results). - Representative of Clinical Operation in committee meetings of studies. - Management of subcontracted monitoring activities - Organization and management of International meetings See less

1- Pragmatic Randomized Clinical Trial - Type II diabetes - GLP-1a - Partnership with US based company 2- Phase IIIb - United Arab Emirates - Type II diabetes - GLP-1a - Partnership with US based company - ensure implementation and follow up of clinical studies at the operational level in compliance with accepted constraints of quality, time and budget. - Functional leader of local responsible of studies. - Reporting to hierarchy with Scientific and operational feedback - Responsible of feasibility studies (lead process and analyses of the results). - Representative of Clinical Operation in committee meetings of studies. - Management of subcontracted monitoring activities - Organization and management of International meetings

Paediatric - Ophan disease - Duchenne Muscular Dystrophy (Phase IIa study) - ensure implementation and follow up of clinical studies at the operational level in compliance with accepted constraints of quality, time and budget. - Functional leader of local responsible of studies. - Reporting to hierarchy with Scientific and operational feedback - Responsible of feasibility studies (lead process and analyses of the results). - Representative of Clinical Operation in committee meetings of studies. - Management of subcontracted monitoring activities - Organization and management of International meetings

Biologic Agent - Orphan disease area (in charge of 4 phase III studies). Partnership with US company (based in San Franscico) - ensure implementation and follow up of clinical studies at the operational level in compliance with accepted constraints of quality, time and budget. - Functional leader of local responsible of studies. - Reporting to hierarchy with Scientific and operational feedback - Responsible of feasibility studies (lead process and analyses of the results). - Representative of Clinical Operation in committee meetings of studies. - Management of subcontracted monitoring activities - Organization and management of International meetings

Metabolism division, in orphan disease area (1 phase II study, and 3 phase III studies). Partnership with US company (based in San Franscico) Writting and validation of protocol Offer to tender, choice of CRO, set up of study and management of CRO for central laboratory and IRS. writting of study documents (Standart Operating Procedure study specific, study forms, study guides...). Set up of study, meetings (monitors and investigators)

Morbi mortality Study - 48 countries - 12 000 patients Set up of Interactive Response System (from offer to tender to go live) then follow up. Set up of Quality of Life ancillary study (Protocol, selection of questionnaire, set up of questionnaire...) Set up and follow up of Pharmacogenomic ancillary stuy Set up and follow up of Biomarkers ancillary study. Set up of Therapeutic Unit (for all the study and all countries)

Responsible of IVRS and Therapeutic Units management in an internationnal morbi-mortality study (34 countries, 800 sites, 11 000 patients) - Management of IVRS company (Clinphone) - Supplies of Countries and Sites - Management of destruction of TU used and unused - Management of database - Clinical study report, Sponsor file management

dispensation of drug to patients