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.
- 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
- Languages: French & English (fluent), Spanish (spoken)
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.