Madrid, Community of Madrid, Spain
I turn complex R&D and clinical data into decisions that advance programs. My work spans team leadership in highly competitive and regulated R&D environments including Pharma, Biotech, and Global Health/Non-Profit Orgs. I serve projects supporting clinical operations and regulatory affairs translating clinical and business needs into clear actionable plans, product & process documentation and successful execution across HealthTech, medical information and pharmacovigilance. Supported by 10+ years of R&D and pre-IND and 2+ years in Life Sciences Consulting, I excel at breaking down silos and aligning complex data with both regulatory requirements and business strategy. I shape ambitious projects with a clear vision and pitch them convincingly, while consistently operating in highly collaborative cultures grounded in a united team vision, structured methodologies, regulatory compliance, and a strong commitment to risk management. Life Sciences Consulting and Program Management • End-to-end consulting delivery across HealthTech, Medical Information, PV, and Clinical Ops • Cross-functional PM: stakeholder and client engagement focused on implementation, delivery and execution, providing clinical, technical and regulatory advisory to the client • Product lifecycle management, budget, regulatory governance and on-site or remote cross-functional team coordination • AI and agentic-driven workflows for medical information synthesis and operational efficiency • Experience in end-to-end validation of operational and technical workflows in-house and client facing roles (ISO 15189, LIMS - IVD-Dx). Clinical Data and Analytics • Clinical database architecture, biomedical ontologies, and RWE analytics • Data governance and quality systems (ICH/GCP, GDPR, ISO) • Scientific communication and KOL development across therapeutic areas R&D and Scientific Strategy • Pre-IND protocol strategy and preclinical regulatory operations • De-risking preclinical assets through pre-IND GLP/GCP-compliant development • PK, toxicology, and analytical validation of preclinical programs • Vaccines, immunology, and oncology research across academic and industry settings Regulatory • Clinical research operations in studies with 200+ participants • ICH/GCP and HIPAA/GDPR governance in clinical studies and implementation in SaMD and Health Apps • Experience in highly regulated environments (GCP/GLP; BSL-1 to BSL-3) • Rigorous documentation standards and traceable decision-making; solid foundation in GMP/ICH, ISO 13485:2016 QMS-MD guidelines • Regulatory document prep, reporting & audit leadership
In this role I bridge the gap between complex oncology data, clinical trial selection, and patient-centric digital solutions. HEALTH-TECH PRODUCT LIFECYCLE MANAGEMENT & REGULATORY GOVERNANCE • End-to-End Delivery: Managed the full product lifecycle of a Clinical Trial Health App, from proof-of-concept to beta testing; serving as the primary operational lead and trusted advisor for executive stakeholders, cross-functional team coordination and vendor management. • Compliance & Data Privacy: Owned the data management workstream for a global health app, ensuring strict adherence to GDPR/HIPAA standards, scope, and quality timelines directly reporting to the operations director. CROSS-FUNCTIONAL COORDINATION & EXECUTIVE STAKEHOLDER ENGAGEMENT • Coordinated cross-functional IT, Education, and Operations teams using Notion, ClickUp, and Google Workspace across 3 time zones in a client-facing consulting role with direct executive-level stakeholder engagement. • Supported the Director of Operations in budget decision making and resource allocation with direct executive-level stakeholder engagement. • Orchestrated multi-country stakeholder coordination in Latin America for the introduction of new diagnostic technology in Argentina through KOL and provider alignment, enabling a bespoke clinical trial. MEDICAL INFORMATION STRATEGY • Directed scalable data curation for oncology clinical trials producing 100+ trials records in 2 months. • Developed medical and scientific database search strategy, including EMA/FDA databases, and implementation of controlled biomedical vocabulary for enhanced searchability; designed agentic AI workflows to automate data entry and medical literature synthesis. • Led Digital Architecture coordinating mapping technical requirements of the Health App with UX needs. • Led the creation of 20+ expert-level oncology educational decks and scientific Q&A dossiers for a global patient community (Colontown).
PRECLINICAL STUDY DESIGN & REGULATORY APPROVALS • Oversaw end-to-end VMP for the installation, validation, and operational workflows of 2 in-house BSL-II laboratories (GLP/GCP – academic setting) • Drove approval of a research license (50+ protocols) with 100% approval and 98% audit compliance • Directed 2 GLP-compliant preclinical pipelines for pre-IND asset de-risking: toxicity, PK, biodistribution, ED50, and efficacy TRANSLATIONAL ASSET DEVELOPMENT • Owned end-to-end preclinical study planning, design, execution, analysis, and reporting for immune-activating compounds • Delivered 2 patentable IND-ready assets and contributed to an oncology spin-out company PRECLINICAL-TO-CLINICAL PROGRAM LEADERSHIP • Led 3 parallel programmes from preclinical proof-of-concept to clinical study development • Oversaw cross-functional teams of 5–15 (scientists, clinicians, nurses) for 5+ years CLINICAL GOVERNANCE & REGULATORY AFFAIRS • Led ICH/GCP and GDPR governance for human research; 100% first-submission protocol approval • Co-PI for a longitudinal observational study enrolling 200+ participants over 2+ years SOPs, FUNDING & OPERATIONAL EXCELLENCE • Created technical SOPs that improved sample recovery by 40%; supported a human specimen biorepository • Secured €875K in competitive funding; achieved 20% cost savings via strategic procurement RISK MITIGATION & SCIENTIFIC OUTPUT • Managed protocol deviations and risk mitigation during COVID-19 to protect timelines • 10 high-impact publications, IP filed as inventor (WO2021123430A1), 100% student graduation rate SCIENTIFIC WRITING & PUBLIC ENGAGEMENT • Directed a 5-year national communications strategy for the Irish Society for Immunology: website overhaul, immunology news blog, and 3 public media campaigns with pharma and media partners • Delivered invited national and international presentations promoting infectious disease awareness and vaccination
• Lectured undergraduate and Postgraduate (MSc & PhD) Students in Immunology & Infectious Diseases • Development of tutorials to support and expand learning. • Development and updating of the educational curriculum. • Adaptation of the course and examinations to the virtual environment during the COVID-19 pandemic.
• Engaged in international collaborations with the European Network of Vaccine Adjuvants (ENOVA) Consortium, spearheading testing of 5+ novel candidate adjuvants and coordinated multi-institutional technical cooperation training programs, managing planning, progress monitoring, and reporting to funders and institutional stakeholders. • Led full project lifecycle from ideation through strategic planning and competitive funding acquisition (€118,000 over 24 months, with 12% procurement savings) to study determinants of susceptibility to respiratory pathogens, with full accountability for budget management and funder reporting across 50+ deliverables. • Published original research as senior author in The Journal of Immunology and contributed to 5 peer-reviewed publications, including Immunity, Cell Reports, and Vaccine. • Awarded the ‘Thomas Mitchell Medal of Excellence of Excellence 2017’, the highest postdoctoral distinction in Ireland in the category of science, technology, engineering and mathematics. Awarding body: Irish Research Council. • Mentored of 2 international MSc students, 5+ undergraduate students.
This teaching position involved creation of the course curriculum, preparation and delivery of lectures of the Basic Community Clinical Cycle of the Medical degree at the Faculty of Medicine of the University of the Republic – Uruguay, Course Haematology, Physiology & Basic and Applied Immunology:
Field Specialist at the Scientific-Tech Department of the company. My main responsibility was to help clinical labs adopt new IVD-Dx technologies and automated workflows through delivery of personalised in-house training. • Co-managed end-to-end installation, equipment validation, and operational workflows for private clinical labs (ISO 15189 & LIMS). • Consulted on molecular diagnostic method validation/qualification (ISO 15189) and delivered on-site training for 10+ hospitals and 8+ clinical labs. • Built scientific relationships with 20+ KOLs across 8+ LATAM countries, informing product strategy and enabling adoption of molecular diagnostics workflows. • Delivered training programs for 10+ hospitals and clinical labs across Latin American countries and coordinated across R&D, Sales, Marketing, and Medical Affairs for 10+ product implementations. • Drove revenue growth and national technology acquisitions through strategic planning, contributing to national approval of automated diagnostic workflows and tuberculosis testing platforms in a Latin American country.