Michelangelo Barone, Md Email and Phone Number
Accomplished senior leader with over 20 years of experience in clinical development, trial operations, and medical affairs within the pharmaceutical and biotech sectors. Adept at steering complex clinical research projects from inception to market, contributing to the approval of seven novel compounds across a spectrum of therapeutic areas including Diabetes, Endocrinology, Cardiovascular, Gastroenterology, Infectious Disease, Vaccinology and Rare Diseases. Proven expertise in regulatory submissions (FDA, EMA) and inspections, alongside extensive experience in leading large, cross-functional teams globally. A strategic thinker with a strong business acumen, capable of aligning clinical development with corporate objectives to drive growth, optimize operations, and enhance organizational productivity.
Wellcome Leap
View- Website:
- wellcomeleap.org
- Employees:
- 41
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Senior R And D Consultant | Clinical And Regulatory Strategy | Rna-Based Therapeutics And Vaccines |Wellcome LeapRome, It -
Global Head Clinical Science - Corporate R&DAlfasigma Sep 2019 - Apr 2024Bologna, Bo, ItI am responsible for directing and overseeing all preclinical and clinical development projects inthe Alfasigma portfolio ensuring scientific coherence across the projects leading Clinical Research/Clinical Sciences organization comprising of PreClinical & ClinicalPharmacology Unit, Clinical Development Unit, Clinical Trial Operations Unit, DataManagement Unit, Biostatistics Unit and Clinical Innovation & Operational Excellence Unit.I am responsible for the strategic planning, implementation, oversight, and close-out of clinical studies.I provide functional and operational direction to ensure studies are completed on time,within budget, and in compliance with regulatory expectations and company SOPs.I work closely with Medical Affairs, Regulatory Affairs, Quality Assurance, and otherinterrelated disciplines to support company goals.I am responsible for the outsourcing strategy through the selection and management of Contract Research Organizations (CROs) and other external vendors for company-sponsored clinical trials. -
Region Director Clinical Development EuropeMerck Sep 2017 - Sep 2019Member of the EU Clinical Development Team, responsible for the Cardiovascular and Metabolic programs in Europe, including trial design, execution, analysis, reporting of Phase II through IV clinical studies in the Region;Member of the Global Clinical Development Team, contributes in designing the clinical development strategy for the entire pipeline in the TAs
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Chief Medical OfficerHumabs Biomed Mar 2017 - Sep 2017Bellinzona, ChAccountable for transferring preclinical projects into clinical phase and for global clinical development strategy for new early projects targeting infectious diseases (Hep B, RSV etc) -
Clinical & Epidemiological Research & Development Project Lead – Global DevelopmentGsk Dec 2015 - Mar 2016Brentford, Middlesex, GbLeads the Clinical Development Program(s) (CDPs) and the Global Epidemiology Plan(s) (GEPs) for an asset or portfolio of assets. Accountable for the development, execution and oversight of Phase I through IV clinical and epidemiological studies, including the integration of global consideration into strategic decisions. Ensures alignment of the CDP and GEP with the Global Regulatory Plan, Medical Plan, and overall strategic product development. Ensures that the protocols, reports, publications and clinical regulatory documents are of highest scientific, operational and ethical standards and are completed in time and on budget. Collaborates with Quality and Compliance to ensure high quality execution of the CDP and GEP. Accountable for the medical and human safety aspects of the clinical and epidemiology programs. -
Ad Interim Global Head Global Clinical Trial Operations- Global Clinical DevelopmentGsk Mar 2015 - Jan 2016Brentford, Middlesex, GbLeading a function of approximately 350 people responsible for the end to end process related to the trial delivery and execution at global level. Leading the integration process of the Global Monitoring Organization of Novartis Vaccines within Global Developmen -
Head Of Global Clinical Trial Operations - Region Europe - Global Clinical DevelopmentNovartis Vaccines And Diagnostics Jan 2013 - Dec 2015Basel, Baselstadt, ChAccountable for the Clinical Development/Operations strategies and activities in Europe, including trial planning, design, allocation, execution, analysis, reporting and publication of scientific data as well as for interaction with Regulatory authorities (i.e. EMEA).Accountable for the effective management (proper planning, allocation and management of the human and financial resources at Regional level) of the partnership with preferred providers (i.e Vendors, CROs etc), resources management (team of 100 people with 9 direct reports; Budget: 25 Mio €) and allocation across programs running in the Region. -
Chief Medical Officer Southern EuropeNovartis Vaccines And Diagnostics Jun 2007 - Dec 2012Basel, Baselstadt, ChAccountable for the Clinical Development strategies and activities in Southern Europe (Portugal, Spain, France, Italy, Albania, Greece, Israel, Turkey), including trial planning, design, allocation, execution, analysis, reporting and publication of scientific data;Accountable for the effective management (proper planning, allocation and management of the human and financial resources at Sub-Regional level) of the partnership with preferred providers (i.e Vendors, CROs etc), resources management (team of 25 people with 4 direct reports; Budget: 8 Mio €) and allocation across programs running in the Sub-Region. -
Italian Local Safety OfficerNovartis Vaccines And Diagnostics Aug 2008 - Apr 2009Basel, Baselstadt, ChManagement of PV activities in Italy (collection, processing, quality control, coding, classification, medical review and reporting of ICSRs, relationship with Health Authorities and health care professionals for Safety issues, interaction between safety issues and products defects, handling of urgent safety restrictions and safety variations, pharmacovigilance activities applying to all products etc..). -
Lipitor Medical LeadPfizer Pharmaceuticals Jul 2005 - Jun 2007New York, New York, UsResponsible for Medical Affairs supporting primarly Atorvastatin and more broadly the whole cardiometabolic portfolio in close collaboration with Sales, Marketing and Market Access Departments. Managing all the Investigators Initiated Trials from proper assesment, establishing partnership with proponent and supporting set up of the IITs (approximately 15 Investigators Initiated Trials); -
Endocrine Care Franchise Medical LeadPfizer Pharmaceuticals Apr 2004 - Jul 2005New York, New York, UsMember of the Global Clinical & Research Team responsible for the Clinical Development Plan of an orphan drug for the treatment of GH- secreting adenoma Pegvisomant (Somavert) and for the Pfizer Growth Hormone (Genotropin);Responsible for Medical Affairs supporting primarly Growth Hormone (Genotropin), Da-Agonist Cabergolin, Pegvisomant (Somavert) and more broadly the whole endocrine portfolio in close collaboration with Sales, Marketing and Market Access Departments. Managing all the Investigators Initiated Trials from proper assesment, establishing partnership with proponent and supporting set up of the IITs (approximately 15 Investigators Initiated Trials) -
Diabetes Medical LeadNovo Nordisk Nov 2000 - Apr 2004Bagsværd, DkResponsible for generating and implementing the medical strategy for the entire Diabetes portfolio (7 drugs in life cycle management and 4 to be launched) in alignment with the overall therapeutic area and Country’s objectives including leading scientific interactions with the local medical community, coordinating the company publication activities and educational projects for physicians and Field Force Scientific Training (45 Reps);
Michelangelo Barone, Md Education Details
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The University Of Chicago Pritzker School Of MedicineVisiting Researcher In Endocrinology And Metabolism -
Università Di CataniaBoard Certification In Endocrinology And Metabolism 1995-2000 -
Guy'S And St Thomas' Nhs Foundation TrustVisiting Researche -
Università Di CataniaMedicine
Frequently Asked Questions about Michelangelo Barone, Md
What company does Michelangelo Barone, Md work for?
Michelangelo Barone, Md works for Wellcome Leap
What is Michelangelo Barone, Md's role at the current company?
Michelangelo Barone, Md's current role is Senior R and D Consultant | Clinical and Regulatory Strategy | RNA-Based Therapeutics and Vaccines |.
What schools did Michelangelo Barone, Md attend?
Michelangelo Barone, Md attended The University Of Chicago Pritzker School Of Medicine, Università Di Catania, Guy's And St Thomas' Nhs Foundation Trust, Università Di Catania.
Who are Michelangelo Barone, Md's colleagues?
Michelangelo Barone, Md's colleagues are Thomas Weiser, Jonathan Castro, Michelle Karadeema, Phd, Kristin Quick, Susanne Ahmari, Eva Ramos-Fernández, Nate Smith.
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