Bio

PROFILE

Looking to leverage therapeutics’ development excellence across clinical research, business development, R&D to make biomedical innovation a reality come true for patients worldwide.

  • Clinical Research Focus. Clinical Research and Monitoring experience with therapeutics and medical devices. Medical/ Technical Writing. Onsite and remote monitoring (SQV, SIV, IMV, COV).
  • Disease Areas. Cardiovascular, vaccines, oncology, rare disease, interventional cardiology and radiology, orthopedics.
  • Biomedical Industry. Pharma/ Biotech / MedTEch. Contract Research Organizations (CRO). Research study-related activities in a matrix environment for internal & external clients within timelines & budget.
  • Biomedical Research. MSc Biochemistry with extensive experience in clinical and biomedical research. Oncology research. Biopharmaceuticals and nucleic acid-based therapeutics. Bioanalysis of large molecules. Bioanalytical sciences, biomarkers, immunology, cell & molecular biology. Peer-reviewed Scientific Publications and Patents.
  • Managerial Skillset. Master’s in business administration (MBA) with operational and project management skills. Clinical operations, R&D management, personnel supervision, direct report. Founder at gtbC inc.
  • Medical Writing Experience. CSR, CER (EU), Clinical Protocols, Monitoring Plans, Agreements, Budgets, SOPs, Bioanalytical Methods, Validation Reports and Protocols.
  • Communications. HCP interactions, Presentations, Conferences, Marketing Material, Posters, Contract Negotiation, Peer-reviewed publications. Chair Bioanalytical Panel AAPS. Soft skills, Executive Focus, Governance Committees.

SKILLS

  • Soft Skills • Engagement • Detail-oriented / Results-oriented • Team-focus / Client-focus
  • Compliance: GCP (ICH E6 R2) Clinical Study Management • GCP Training 2020 • MedDev ISO 14155:2011 • 21 CFR Part 11 GLP (21 CRF Part 58)
  • Disease: CAD • PAD • Rare Disease • Vaccines • Biopharmaceuticals • Biomarkers • Ostheoarthritis Oncology course & research
  • IT: iMedidata, IBM eClinical, Medrio, Omnicomm, Oracle EDC iMedidata & Oracle CTMS • LIMS • SAP • Salesforce • Concur • IWRS • IRT • SureClinical TMF • Florence eISF • CRIO eSource/eReg
  • Other IT: WordPress, Php, MySQL, Javascript
  • Languages: French & English (fluent), Spanish (spoken)

Research

Basic and applied research in molecular and cell biology. R&D in biotech. Interested in Biopharmaceuticals / Biotech Innovation / Gene Therapy / Bioanalysis / Diagnostics / Pharma / Startups / Basic Research.

Nucleic Acids / Biopharmaceuticals / Immunoassays / Hybridization / Ligand-binding Assays / PCR / Oligonucleotide Therapeutics / Cloning & Expression / Virology & Cancer Research / Etc.

As a research scientist/ project manager: development and GLP validation ­over 100 bioanalytical assays for large molecules such as Biomarkers, siRNA, antisense and IgG Therapeutics. Regulatory-compliant work in GLP, GCP and GMP settings and project management.

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