Mario Cruz-Rivera

Global Medical Director - Medical Lead, Rx-to-otc Switch @Sanofi

Wilmington, DE, US
EMAILS
m••••••••@sanofi.com
MOBILE NUMBERS
+18•••••••75

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WORK HISTORY

Apr 2019 — Present

Global Medical Director - Medical Lead, Rx-to-otc Switch @Sanofi

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Bridgewater, NJ, US

Responsible for leading the medical evaluations and due diligence of potential Rx-to-OTC Switch assets in close collaboration with Regulatory Affairs, Clinical, Commercial, Business Development, Competitive Intelligence and other related functions. Accountable for the strategy, design, development, execution, analysis, reporting and delivery of Consumer Label Development programs, including Label Comprehension, Self-Selection and Actual Use Trials, amongst others.In addition: • Define medical priorities and key medical insights in strategic medical plans for portfolio development and prioritization. • Engage with external key opinion leaders and experts to identify new insights, including risks and opportunities, relevant to therapeutic areas of interest and White Space development opportunities. • Develop and engage Advisory Boards for pipeline molecules, and leading the preparation for the medical presentations to the external stakeholders. • Ensure high quality and timely medical deliverables, including studies; BoH briefing documents, dossiers, and other high-level submission documents; and medical, clinical and scientific statements, data and references to support science and claims substantiation. • Monitor, understand and leverage the changing healthcare environment (including regulatory, scientific, social and policy trends) and consumer & patient journeys to anticipate threats and opportunities that may impact patient self-care vis-à-vis the Consumer Health Care portfolio.

EDUCATION

1983 — 1988

The University of North Carolina at Chapel Hill

PhD, Chemistry

1988

The University of North Carolina at Chapel Hill

Doctor of Philosophy - PhD, Chemistry

1996 — 1998

UMass Chan Medical School

MPH, Epidemiology & Biostatistics

1975 — 1981

Universidad de Puerto Rico

BS, Biology

SKILLS

Clinical MonitoringTranslational MedicineCtmsBiotechnologyCROGcpGastroenterologyPharmaceutical ResearchBiomarkersDrug DevelopmentDrug DiscoveryTherapeutic AreasIch-GcpHealth EconomicsGlpBiologicsClinical Study DesignRegulatory SubmissionsClinical PharmacologyPharmacokineticsBiostatisticsMedical AffairsNeuroscienceBiopharmaceuticalsFdaRegulatory AffairsEdcRespiratory DiseaseSopIndPharmaceutical Industry21 Cfr Part 11Clinical DevelopmentPharmaceuticsAsthmaNeurologyPharmacologyDrug SafetyClinical TrialsProtocol

ABOUT MARIO CRUZ-RIVERA

Experienced & accomplished Sr Global Clinical Development Director, with >30 years of…

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