Acerca de Marie Gabrielle
I am a physician specializing in Internal Medicine with 20 years of clinical practice. My professional expertise lies in the "translational bridge"—the ability to convert complex laboratory measurements into meaningful clinical, safety, and regulatory decisions. As an International Regular Member of the American Society of Pharmacology and Experimental Therapeutics (ASPET), I provide an elite, end-to-end perspective on the entire drug development lifecycle.
The Foundation: Laboratory Science & Clinical Investigation
My career began in the lab as a Medical Technologist during the transition from manual to automated chemistry, which trained me to understand the technical nuances of pre-analytical and analytical variability.
I have served as a Clinical Investigator and Sub-investigator for Phase I–III studies with global leaders including SNBL INA Research Japan, Menarini, and Novartis AG. My core industry expertise is in Clinical Pharmacology and PK/PD, where I have managed:
- Early-Phase Diagnostics: Proof-of-concept metabolic studies (e.g., 1,5-anhydroglucitol).
- Safety Assessment: Thorough QT/QTc exposure–response studies correlating ECG findings with plasma drug concentrations.
- PK Characterization: Randomized crossover studies determining Cmax, Tmax, AUC, and clearance.
Data-Driven Clinical Strategy & Authorship
I bridge the gap between medicine and tech with a Postgraduate Diploma in Computer Applications specializing in Biostatistics and am currently completing HarvardX’s Professional Certificate in Data Science. This allows me to design protocols and CRFs that are optimized for biostatistical analysis and real-world evidence.
I am also a published author of two textbooks used in Philippine universities: Pharmacology for Allied Health Professions and Essentials of Medical Terminology. My research on phthalate esters as endocrine disruptors was published in the inaugural edition of the Philippine Journal of Experimental and Clinical Pharmacology.
Inglés
Bilingüe o nativo
Español
Competencia profesional completa
Filipino
Bilingüe o nativo
Francés
Nociones
Acepta trabajo presencial
Alicante (hasta 50 km)
Experiencia
- Eurawest TechnologiesDirectorenero de 2025 - Hoy (1 año y 5 meses)Sofia, BulgariaElite Digital Health Agency: Lead a full-service digital marketing and IT organization specialized in the global MedTech and healthcare sectors, serving as the European sister company to Eternus Global.Medical Digital Advertising: Drive market dominance for health clients through specialized PPC (Pay-Per-Click), SEO, and comprehensive digital growth strategies.Health Medical Cybersecurity: Implement robust, HIPAA/GDPR-compliant security frameworks for medical devices and health information systems, focusing on threat modeling and risk mitigation.Translational KPO Services: Provide high-end Medical Knowledge Process Outsourcing (KPO), including regulatory-compliant medical writing and biostatistical analysis for global pharma and biotech firms.Market-Entry Strategy: Guide international medical brands through complex European regulatory landscapes (EMA/GDPR) to ensure successful cross-border market entry.Full-Stack Health Tech: Oversee the development of secure, scalable web and mobile applications tailored for clinical environments and patient-facing digital health services.Branding for Life Sciences: Execute evidence-based branding and communication strategies that translate scientific excellence into compelling market narratives.Data-Driven Growth: Leverage background as a physician and data scientist to deliver biostatistical insights that optimize digital advertising ROI for pharmaceutical clients.
- SNBL - INAClinical InvestigatorINDUSTRIA FARMACÉUTICAnoviembre de 2010 - diciembre de 2014 (4 años y 1 mes)Ina, JapónPhase I/II Clinical Leadership: Led combined Phase I and II clinical trials for both investigational drugs and functional food products.Regulatory Bridging: Expert in ICH GCP with a specialized focus on harmonizing Japanese (PMDA) and European (EMA) regulatory standards, supported by SNBL’s international presence.Principal Investigator (1,5-AG): Directed Phase I/II efficacy and safety studies for 1,5-Anhydroglucitol in diabetic populations to assess metabolic outcomes.Biomarker Validation: Established 1,5-AG as a precise clinical biomarker for tracking short-term glycemic variability and postprandial glucose excursions.Cardiovascular Safety (Sub-I): Conducted Thorough QT/QTc (TQT) exposure-response studies specifically for the safety profiling of quinolone antibiotics.PK/PD Precision: Managed rigorous sampling and timing protocols to correlate plasma drug concentrations (Cmax), AUC) with cardiac safety (ECG) data.Translational Strategy: Transformed complex laboratory measurements into actionable clinical insights for early-phase metabolic and cardiovascular research.Global Data Integrity: Ensured high-level data compliance and biostatistical consistency for multi-region submissions across Asian and European markets.
- Eternus Global Co. LtdManaging DirectorBIOTECNOLOGÍAmarzo de 2016 - diciembre de 2024 (8 años y 9 meses)Manila, FilipinasMedical KPO Leadership: Directed a specialized Medical Knowledge Process Outsourcing (KPO) firm since 2016, providing high-level clinical and scientific services to pharmaceutical and biotech companies worldwide.Interdisciplinary Collaboration: Partnered with a microbiologist and bioinformatician to offer an integrated approach to medical writing and outsourced clinical research.Phase IV & Real-World Evidence: Designed and managed post-marketing (Phase IV) and real-world studies, including the development of protocols, Case Report Forms (CRFs), and IRB submissions.Biostatistical Excellence: Led biostatistical analysis and data modeling using R, SAS, and Python to translate clinical trial data into meaningful regulatory decisions.Health Information Systems: Oversaw the development of secure health information systems and HIPAA/GDPR-compliant health informatics platforms for global clients.Pharmaceutical Advisory: Provided strategic advisory services for the pharmaceutical industry, focusing on regulatory-compliant growth and international market-entry strategies.Scientific Authorship: Directed medical writing teams for international pharmaceutical clients, ensuring scientific accuracy and clinical relevance.Industry Recognition: Eternus Global was recognized by BestStartup.asia as one of the "101 Top Southeast Asia SEO Companies and Startups" for its data-driven approach to digital health growth.
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Formación
- Doctor of Medicine - MD, completed Residency Training in Internal MedicineIloilo Doctors' College of Medicine2004Rank 6 in medical graduating class, diplomate and fellow in internal medicine
- Bachelor of Science in Medical Technology (Medical Laboratory Science)University of San Agustin2000Licensed medical technologist, board topnotcher
Certificados
- EF SET (Rated with C2 English)Common European Framework of Reference (CEFR)2025
- Professional Certificate in Digital MarketingiMarketer London2018
Conjunto de habilidades profesionales
Categorías
- Otros