Experience

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  Dr. n. kahal's pharmacy

  Jul 2008 - Sept 2008

  Internship in pharmacy practice
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  Sheffield teaching hospitals nhs foundation trust

  Jul 2010 - Aug 2010

  Internship in biomedical research

  Research theme: Characterizing mi-RNA expression in Mononuclear Cells in Peripheral Blood (MCPB) of patients with Acute Coronary Syndrome (ACS).Research grant: NHS Foundation TrustSupervisors: Dr. Alison MORTON, Dr. Sara LANGRIDGE, Dr. Alex ROTHMANResponsibilities:- Patient recruitment for biomedical research.- Blood sampling and sample racking in the biorepository.- Total and mi-RNA extraction, characterizing, and quantification.- Data analysis and interpretation.Technical skills:- Beckman Coulter Biomek FXP Laboratory Automation Workstation monitored by Biomek Software.- Beckman Coulter Paradigm Detection Platform managed by SoftMax Pro 6.1.- PAXGene Blood RNA System, PreAnalytix.- Taqman Low-Density Array RT-qPCR (SDS miRNA Human_A TLDA Card & HT 7900 Fast Real-Time PCR, Applied Biosystems).- GraphPad Software, Inc., San Diego, CA.- Thermo Scientific Nanodrop 2000 Spectrophotometer.- BIO-RAD Mini-PROTEAN ® Tetra System. Show less

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  Msd

  Apr 2012 - Jun 2012

  Internship in applied bibliographic research

  Research theme: Confidential.Supervisor: Dr. Erwin VAN DEN BORN

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  Université paris-saclay

  May 2013 - Jul 2013

  1st-year of masters internship in biomimetic drug synthesis

  Research theme: Biomimetic Synthesis of Pleiocarpamin, a Natural Alkaloid of Antiamebian and Cytotoxic Activity.Supervisors: Pr. Erwan POUPON, Dr. Laurent EVANNOBioCIS, CNRS UMR 8076

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  Centre national de la recherche scientifique

  Jan 2014 - Jul 2014

  2nd-year of masters internship

  Supervisors: Dr. Fanny ROUSSI, Dr. Sandy DESRATResponsibilities:- Gram-scale multi-step organic synthesis, purification, and structural characterizing.- Pharmacomodulations, Structure-Activity Relationship (SAR) analysis.- Bibliographic research, data analysis, and presentation.

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  Université paris-saclay

  Feb 2015 - Nov 2017

  Research theme: Design, synthesis, and biological evaluation of small molecules inhibitors of anti-apoptotic proteins of the Bcl-2 family.Research grant: ARC Foundation for Cancer ResearchSupervisors: Dr Fanny ROUSSI, Dr Sandy DESRATResponsibilities:- Gram-scale multi-step biomimetic organic synthetic pathway, molecule purification, and structural characterizing.- Batch production optimization: toxicity minimization and cost optimization.- Pharmacomodulations, Structure-Activity Relationship (SAR) analysis.- Implementation and robotization of a fluorescence polarization inhibition assay.- High throughput screening and evaluation of biological activity through a fluorescence polarization inhibition assay.- Protein bioproduction and purification.- Protein-protein interaction study and analysis.- Data analysis and presentation: Author/co-author of 4 scientific articles, speaker at 3 European conferences.Technical skills:- Anton Paar MCP 300 polarimeter.- BUCHI Melting Point B-540.- RMN Bruker UltraShield managed by TOPSPIN 2.1.- UPLC-MS Bruker – MassLynx.- Chiral HPLC.- Flash liquid chromatography: CombiFlash© Rf 200i – TELEDYNE ISCO.Scientific Communications2017: “European Federation of Medicinal Chemistry, Young Medicinal Chemist Symposium”, Austria, Poster and flash oral presentation.2017: “Journée de l’Ecole Doctorale Innovation Thérapeutique”, France. Oral presentation.2016: “The 20th Meeting of Young Research Fellows in Cancerology”, France. Poster presentation.2016: "Journées de Chimie Organique", France. Poster presentation.2016: "Rencontres en Chimie Organique Biologique", France. Poster presentation.2015: “The 19th Meeting of Young Research Fellows in Cancerology”, France. Poster presentation.2015: “European School of Medicinal Chemistry”, Italy. Prize-winning poster and oral presentation. Show less

  • PhD Fellow

    Oct 2014 - Nov 2017

  • Teaching (theory and practice)

    Feb 2015 - Mar 2016
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  Hybrigenics

  Apr 2018 - Oct 2018

  Clinical research associate in hematology-oncology (cra i)

  Efficacy study of Inecalcitol in combination with Decitabine in acute myeloid leukemia patients unfit for standard chemotherapy.Phase II, international multicentre study: 16 sites in France, 3 sites in Belgium, 3 sites in Germany, 15 sites in Spain, and 14 sites in the USA - Total: 115 patients.Responsibilities:- Monitoring visits to 5 sites and pharmacies in France, an average of 2 visits per week.- Remote monitoring of 5 sites in France and 7 sites in the USA.- Coordination with multinational CROs and subcontractors in Europe and the USA.- Regulatory drafting and submission: ANSM, CPP, WIRB (change of PI, protocol amendments, end of accrual notification, early termination of a clinical study). - Pharmacovigilance management of the study (processing, follow-up, documentation, transmission).- Site staff training on protocol amendments.- Study documentation maintenance (TMF, Investigator, and Pharmacist's Files on site, paper/electronic).- Design and maintenance of study trackers (Treatment cycles, scheduled blood tests, IMP receipt and dispensation, protocol deviations, SAEs, site logistics, and study documents).- Pharmacy relabeling campaigns, control of stock levels, storage condition, and prescription forms.- Biological test results processing, monitoring, and transmission to data management.- Site budget management, and invoicing proposals.- Close-out visits of 10 sites and pharmacies (France, Belgium, and the USA remotely).Vendor Experience:- Drug Safety Services: AB-Cube SafetyEasy. Show less

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  Anticipsante

  Nov 2018 - May 2019

  Drug safety and medical information officer

  • Detection, understanding, and prevention of unwanted side effects. • Management of cases of pharmacovigilance, cosmetovigilance, materiovigilance, and nutrivigilance transmitted through spontaneous notifications or clinical trials (receipt, documentation, data entry (AB-Cube SafetyEasy), coding (MedDRA), narrative writing, company comment, evaluation of causality and imputation (Begaud/French method, WHO-UMC system).• Hotline for pharmacovigilance and medical information during and off-working hours.• Weekly literature watch in French and international medical journals.• Signal Detection Report writing.• Product training and client advice.• Development and improvement of operations and procedures of AnticipSanté and its clients.Vendor Experience:Drug Safety Services: AB-Cube SafetyEasy. Show less

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  Axonal-biostatem

  May 2019 - Oct 2020

  Clinical research associate (cra ii)

  Phase III, Nuclear Medicine, Renal Cell Carcinoma, Telix Pharmaceuticals.Phase Ib/II, Metastatic Renal Cell Carcinoma, AVEO Pharmaceuticals.Retrospective, Nuclear Medicine, Hepatocellular Carcinoma, Advanced Accelerator Applications.Phase I/II, Active chronic non-infectious uveitis (ophthalmology), EYEVENSIS.Major achievements: - Building-up strong, professional relationships with both investigative sites and trial sponsors.- Increasing sites' motivation and patient enrollment after a period of inactivity.- Assuming a backup role to Clinical Project Manager when needed.- Low rate of adverse and serious adverse events observed with trial patients. - Clinical trials qualified for the following phases.- High-quality results of the clinical trials shared at world-renowned conferences.Responsibilities:- Initiating clinical trials at investigative sites, and site personnel oversight of the proper conduct of clinical trials.- Vendor selection and order follow-up and management.- Management of the logistics of Investigational New Drugs (IND) and clinical kits on a European scale.- Management of primary and secondary packaging activities, (re)-labelling, storage and optimization of the supply and distribution strategy in compliance with regulations and budget.- Budget management (Forecasts and Actuals).- Medical training and education of investigative site staff.- Mentoring junior CRAs, and leading observation and performance visits.- Monitoring clinical trials in investigative sites to ensure sponsor and investigator obligations are met and are compliant with applicable local and ICH-GCP guidelines.- Reviewing and verifying the accuracy of clinical trial data collected and query resolution.- Providing regular site status updates to local and global trial management.Vendor Experience: - EDC (eCRFs): Ennov Clinical, Clindex.- Central Lab Services: TDL, Oncodesign.- Central Imaging Services: Duke Reading Center.- Courier: DHL, Marken. Show less

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  The janssen pharmaceutical companies of johnson & johnson

  Oct 2020 - Sept 2022

  Clinical site manager

  Phase III, Cell therapy (CAR-T), Multiple Myeloma.Phase IV, Standards of care (SOC), Multiple Myeloma.Phase II, Paediatrics, Chemotherapy, Acute Lymphatic Leukemia.Major achievements: - An audited clinical site with no major findings.- Meeting timelines while providing high-quality deliverables for quarterly intermediate analyses.- Low rate of serious adverse events observed with trial patients. - Clinical trials qualified for the following phases.- High-quality results shared at world-renowned conferences.Responsibilities:- Development of an online platform providing clinical trial participants with relevant information, informing potential participants about available trials, and giving them insight into a number of medical conditions.- Facilitating audits and resolution of audit findings, issue escalation, CAPA implementation and follow-up.- Management of the logistics of Investigational New Drugs (IND) and clinical kits on a European scale.- Management of primary and secondary packaging activities, (re)-labelling, storage and optimization of the supply and distribution strategy in compliance with regulations and budget.- Budget management (Forecasts and Actuals).- Medical training and education of investigative site staff.- Mentoring junior CRAs, and leading observation and performance visits.- Monitoring clinical trials in investigative sites to ensure sponsor and investigator obligations are met and are compliant with applicable local and ICH-GCP guidelines.- Reviewing and verifying the accuracy of clinical trial data collected and query resolution.- Providing regular site status updates to local and global trial management.Technical Skills:- Clinical Trial Management System: Medidata CTMS.- EDC (eCRF): Medidata RAVE.- IVRS/IWRS/RTSM: Bracket.- Veeva Vault eTMF.- Electronic Medical Records (EMR).Vendor Experience:- Central Lab Services: Hematogenix, LabCorp.- Courier: DHL. Show less

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  Surge

  Apr 2023 - now

  Clinical and r&d project manager

  - Orchestrating end-to-end processes for R&D projects, including clinical trials, encompassing design, implementation, execution, and comprehensive management. Coordinating cross-functional teams, overseeing administrative, regulatory, logistics, supply, and human resources aspects, and ensuring diligent follow-up.- Developing strategic plans for grant appeals at regional, national, and European levels, ensuring a comprehensive approach to securing funding for R&D initiatives.- Crafting strategic plans for scientific dissemination, involving the meticulous selection and tracking of conferences, symposia, and salons, as well as the submission of abstracts to enhance the visibility of research efforts.- Conducting market analysis to inform decision-making, including supplier selection, leading the implementation of effective solutions to drive project success. Show less