Soneil Guptha Md Facc Fesc Fccp Fica Mfpm Gfmd Email and Phone Number
Soneil Guptha Md Facc Fesc Fccp Fica Mfpm Gfmd personal email
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Tool box: - Clinical Development, Medical Affairs, Education & Medical Marketing, e-EDUCATION; Contract/Consultancy/FTTrack record in…... • Drug (device) development NDA & sNDA, IND, IDE submissions or change in labeling, change in practice guidelines and publication in peer reviewed journals. • Development, approval & commercialization of more than 17 IMPs including pediatric exclusivity• Medical affairs and operations including patient access, developing and managing thought leaders and publications in the US, EU and A-PAC, HEOR activities, Sales and MSL training and Subsidiary support world wide for medical information • Business diligence or development as Medical and Scientific Assessor which led to profitable acquisitions and/or salesEXPERIENCE-PERFORMANCE-QUALITY as - Departmental head, supervisor of teams and administer of budgets - Expert witness for regulatory agency- Alliance Manager and liaison for joint development or commercialization teams- Academic partner (Pfizer Pfellowship, IFAPP-Kings)- Member of Public private task forces/committees/consortiums (for QCA, IVUS, CSRC, ESC)- Invited author, visiting lectures, Book chapter, Peer reviewer, Co-editor of journal- Licensed physician and past professor - Practitioner of Internal medicine, Cardiometablic therapeutics and Interventional cardiology
Centre For Pharmaceutical Medicine Research, King'S College London
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Visting Sr LecturerCentre For Pharmaceutical Medicine Research, King'S College LondonSt. George, Ut, Us -
Visting Sr LecturerCentre For Pharmaceutical Medicine Research, King'S College London Aug 2024 - PresentGreater London, England, United Kingdom -
Adjunct ProfessorRocky Vista University Jul 2024 - PresentUnited States -
Adjunct ProfessorPacific College Of Health And Science Oct 2017 - PresentSan Diego County, California, United States -
Co-Founder & Chief Academic Officer4 H-C.A.R.E. (Self-Employed) Jan 2016 - PresentUnited StatesExperienced Executive, Boards, Committee, working groups, task force memberEntrepreneurial contractor and corporate team leaderClinical Development, Medical Affairs, Education & Medical MarketingCardio-Metabolic Medicines and Therapeutics and device developer, Educationist, Academic, Researcher Strategic forward thinker, Analytic solution finder utilising facts/data experiences in decision making, Polished articulator, orator, communicator,Guide coach and mentor
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Board MemberGmdp Academy (Previous Ifapp Academy) Aug 2016 - PresentUnited StatesFounder Director of the Academy with Dr Allen (RIP) and Dr Silva. involved in original development, launch and continuing evaluation of the elearning offerings of the academy. Now Board Director and Advisor to the Executive Committee of the IFAPP-Academy
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Sr Md - Clinical Research & Medical AffairsWorldwide Clinical Trials Holdings, Inc. May 2018 - Oct 2022United StatesMedical Monitor - Cardio vascular, Diabetes, Renal, Early phase and Rare diseases -
Vice President, Medical & Scientific AffairsIcon Plc Jun 2013 - Aug 2016PennsylvaniaI was responsible for end to end development expertise in Cardio-metabolic drug and device development, CV Imaging, CV Outcomes trials and Medical Affairs. This responsibility was serviced by consultation and leadership performance as internal KOL and to partnering clients in the industry academia regulators and educators. -
Attending Cardiologist & Research Physician ScientistSanjeevani Hospital And Fortis Hospital, Jaipur Mar 2009 - Dec 2012Jaipur Area, IndiaClinical cardiologist and Internist
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Medical Affairs ConsultantNational & Mncs May 2009 - Dec 2011Consultant to Industry, Reglatory agenies, Pharmacie, Hospitals and academics on Cardio-metabolic Clinical development, Medical Affairs and Medical Marketing
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Regional Director Scientific (& Medical) Affairs - Asia PacificMerck & Co Inc Apr 2007 - Sep 2008SingaporeDeveloped strategic positioning for Merck cardio-metabolic products in Asia pacific region. Lead and supported all medical/scientific and regulatory efforts Launched global clinical trials (1) and regional/national IISP (3) Presented to the regulatory agencies and pricing agencies in Asia PacificLead Regional Scientific Affairs Team and indirect supervisory responsibility of country lead physicians, research coordinators and regulatory officersMember of Global Medical Team, Global Commercial Team, Global Product teamsBudget responsibility of projects -
Senior Medical DirectorMerck & Co Inc Mar 2003 - Mar 2007New Jersey, UsaLead all Global Medical Affairs activities in Europe, Latin America, and Asia pacific including Japan based in HQ (Whitehouse Stn, NJ, USA) for Cozaar/Hyzaar, Zocor, Aggrastat, Cancidas Developed and completed 14 IISPs and two phase IV regulatory trial (LIIFE & HEAAL)Defended CZR/HZR at Bfarm in Germany and EMEAPublications in peer review journals (HEAAL, ON-TIME2, Asia-HEAALTH) and presentations in International conferences (3)Lead global medical team meetings and coached country lead physicians for therapeutic and operational excellenceBudget responsibility for all projects
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Global Medical Director & Head Of Cv Devices & PharmaceuticalsAbbott Laboratories Jun 2001 - Feb 2003Chicago, Illinois, UsaDeveloped a department from scratchLicensed and developed life cycle program for (Corolopam)Direct supervisory responsibility of MDs, PharmD, Phds in departmentDeveloped and successfully completed protocols to support national and international life cycle managementAgreed with FDA and completed pediatric exclusivity (Corlopam)Completed and secured re-license (Abbokinase) Sales training, review of promotional reviewLead the global development teams for Corolopam, Abbokinase and ABT-578 Biocompatible/Endeavour programSupported commercial in- licensing activities (Orion Pharmaceuticals) and alliance management (Biocompatibles, Perclose) for CV projects & devicesSecured IDE for ABT-578 and launched Endeavor stent programDeveloped a portfolio of cardiovascular acquisition targets (Knoll) – Hirudin, Verapamil, Trandpril, Propafenone, and Endothelin Receptor AntagonistsProfit planning for the department and developmental programs -
Senior Associate Medical DirectorPfizer Inc Apr 1995 - May 2001Sandwich Uk & Groton, Ct, UsaPitched successfully and developed International Clinical Research Group (India, China) under supervision of Sr VP Pfizer Clinical ResearchCo-Developed GCP guidelines with Chinese and Indian regulatory agencies and thought leadersStarted and successfully implemented Pfizer Pfellowship program in collaboration with Harvard Medical School and research operations in new theatresTeam member for due diligence activity for Lipitor Lead Phase IV study in hyperlipdemia (Lipitor) in US and international markets. Lead phase III studies in microalbuminuria and neuropathy (Aldose Reductase Inhibitor)Supervisory responsibility of in-house CRAs, outsourced CROsChaired international symposia and executive committees.Budgetary responsibility of lead projectsMember of early development management team for CV projects -
Attending Honorary Consultant SpecialistHammersmith And Charing Cross Hospitals 1990 - 1996London, England, United KingdomHonorary Attending Consulting Specialist in the Hospitals (twice a week) for outpatient care at the MRC Lipoprotein Clinic and BHF preventative cardiac clinic
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Pharmaceutical Physician - Clinical Research & Medical AffairsMerck Sharp & Dohme Mar 1990 - Mar 1995Hoddesdon, Herts UkScientific Leader for commercial development of Zocor and Innovace in UK and Eire, Successful submission and negotiations of subsequent labeling modifications (x3) with MCA/EMEA for Zocor and InnovaceDeveloped, lead and completed approx 54 clinical trialsSales training, promotional review of commercial materialsManaged (local candidate team leader) a team of physicians, CRAs, Biostatisticians and CROs to conduct the phase III program for Aggrastat, Singulair and Losartan in EUCo-chaired National and European symposia and executive committees Provided medical information and safety monitoring to regulatory agency, medical community, public affairs and marketing colleagues. -
Sho (Honorary), Research Registrar, Registrar, Sr Registrar (Tutor), Assistant ProfessorHammersmith, Charing Cross, Kings College, University Of Birmingham, Dudley Road, Good Hope, Guys, S Jul 1975 - Jul 1990Various training positions leading to positions of responsibility in day to day care of the patients, teaching undergraduates and nursing students, supervising junior training staff and managing the interventional cath as well as out-patient noninvasive labs.Sub-investigator for Phase 4 studies in India and UKTeaching UG students and PG fellows and CME for allied health care professionals
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Medical OfficerMedicines Control Agency May 1989 - Mar 1990Vauxhall, London UkProvided professional service (evaluation of safety efficacy and quality of medicines) to the Committee on Safety of Medicines and its sub-committeesLead responsibility of the yellow card scheme for continues safety assessment of cardio-respiratory products Lead Medical assessor (reviewer) post-marketing surveillance studies, Provided safety information to doctors and the pharmaceutical industry. Lead responsibility of medical scrutiny and assessment of patient information leaflets, pack inserts, drug promotion and labelingRepresented the Government (MCA) as lead expert witness on drug defect cases (6)Responded to questions from the Parliament (UK) on Drug safetyDeveloped the first draft of EMEA regulations for Pharmaco-vigilance and patient Information leaflets
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RegistrarKings College Hospital 1988 - 1990Clinical cardiologist and Internist with ineterst in paharmacology and care of the elderly
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