1/ Leader with extensive vaccines development and innovation experience under GMP, coupled with previous managerial expertize in clinical trials development and execussion (phase 0-3) and IT/IS Quality management:
- at mid-size pharmaceutical organizations as Vaccines Development Programme Leader and CSO (IMUNA PHARM SA)
- at one of the biggest vaccine producer as Clinical Publication Project Manager for Therapeutic Vaccines Products (GSK Biologicals)
- at the CRO - BrEAST data center as Clinical Project Manager for global Phase III studies in breast cancer for ROCHE and local Phase 0-I studies (Institute Jules Bordet)
- with whole range of pharma product portfolio (vaccines, immunotherapeutics, phages, monoclonal Ab) and therapeutic areas (infectious disease, oncology, immunology, hematology)
- with crossfunctional and cross border management of multi-national, multi-cultural teams (Asia, India, East Europe, USA)
2/ Leader with excellent corporate affairs and IP responsibilities towards:
- industrial partners for license agreement negotiation (Wistar Institute, NIH, PHE)
- funding bodies (like Ministry of Education), regulators (national drug authorities and regulatory bodies like Ministry of Health), CMOs and CROs.
3/ Leader with unique focus on:
- business results, winning company culture with strong integrity and team work, outstanding motivation, personal passion, respect and open communication
4/ Strategic scientific advisor, writer and reviewer of:
- regulatory justifications, CTD modules, communication towards national regulatory authorities, participated and formulated study design, clinical protocol for phase 0-3 studies, eCRF, informed consent, SAE/AE reporting guidelines, data management plan
- expert scientific reviews and original articles - analytical validation protocols/reports for Ph.Eur./Non-Ph.Eur. methods (Elisa, qPCR, flow cytometry, sterility, cell viability, advantitious agents etc.), SOPs
- technical documentation, validations plans for sterile production under GMP
Medicine Development Leader, Project Manager RD
Since July 2013
Translating CMC life cycle requirements into new product development and innovation within Regulatory Assurance, Quality Control and Manufacturing framework. Activities • Coordination and scientific leadership of 10+ RD and product innovation projects in vaccines and other biologicals across RD, QC and sterile GMP production in collaboration with external partners (academic, CROs, CMOs, NRAs). • Resposible for execution and definition of strategy, timelines, budget, technical and tasks list of 5+ EU funded projects with budget 2-5 millions euros from planning to delivery. • Prepared and led RD throught ISO9001 certification. • Direct line management of 10+ and cross functional people management of 25+. • Focal communication point for NRAs regarding QC/QA, technological processes, validation, pre-clinical and clinical testing. • Provides strategic scientific insight and writing support for regulatory claims, justifications, CTD modules filling and clinical protocols design for phase 0-4 studies. • Monitoring changes in scientific, medical, regulatory, legal and patent requirements. • Reporting to top management (CEO and Board of Directors). Projects • Upstream and downstream process development and validation. • Analytical method development and validation of chemical and biological assays (Elisa, qPCR, flow cytometry, sterility, BET, cell-based assays, HPLC) and transfer to QC. • Technology transfer and process validation. • New vaccine production facility validation and its GMP certification. • Implementation of new technologies into sterile production under GMP. • Development and validation of non- and pharmacopeian pre-clinical in vitro & in vivo models. • Phase 0 translational studies. • Seed lot system (virus, bacteria) & cell bank development with characterization according to WHO, Ph. Eur. (human diploid cell lines, primary cells, continuous cell lines such as MDCK, Vero). • Product formulation, stability studies design & analysis.
QC Coordinator/ Deputy of Head of QC
April 2015 --- April 2016
Providing operational and administrative support to Head of QC, acting as Deputy of Head of QC. Activitites • Training new personnel - GMP requirements, processes and analytical methods. • Task allocation and deadline monitoring. • Expert supporting introduction of new testing methods, their validation and transfer. • Responsible for product stability studies - design, testing and analysis. • Communication with external partners (sub-contractors laboratories, API producers, regulatory authorities). • Deputy of Head of QC - product release, CoA preparation, CAPA management etc. • Writing, reviewing and approval of existing and new SOP and other critical GMP documents such as specifications, methods of sampling, testing procedures and other working procedures related to quality control. • Monitoring of compliance with GMP requirements for sterile drug production (biologicals and vaccines). • Providing expert support during external audit by Czech Republic National Regulatory Authority - SUKL.
Clinical Project Manager (CPM)
January 2012 --- January 2013
Led and coordinated team of Data Managers, IT experts, Clinical Scientists in their daily activities on Global Phase III clinical study in Oncology with aim to satisfy customer, to meet GCP standards and project requirements. Activities • Prepared task list, determined milestones, budget and allocated resources. • Wrote and/or critically reviewed trial documentations IB, protocols, reports, patient summary. • Set-up guidelines and SOPs. • Coordinated activities related to Safety - AE/SAE reporting and reconciliation process, aggregate listings, Clinical Science Review process, Risk assessment, Data management. • Tracked the trial - set up study metric tools for tracking and reporting (weekly for client); assessed adequacy and recommend changes of resources. • Liaised with IT to set up user requirements (USR) for online reporting software applications development, validation and implementation during study (in Oracle Clinical, Jasper). • Acted as a focal point for stakeholders on the assigned projects, kept members informed of developments, created issue ownership, and actions taken. • Performed internal audits of documentations and assured that appropriate SOP and guidelines are in place and up-to-date. • Helped to establish consensus and atmosphere of trust between the client, external and internal stakeholders. Projects • Global Phase III clinical trial in breast cancer - BIG 4-11 (APHINITY): Herceptin® plus pertuzumab adjuvant study with translational endpoints. • Local phase 0-I clinical trials in oncology conducted in-house with translational endpoints.
Clinical Publication Project Manager, c/o XPE Pharma
January 2011 --- January 2012
Lead and coordinated development of clinical publication projects (from planning to delivery) with a multi-disciplinary team of experts to support therapeutical vaccine communications of GSK Biologicals worldwide within ICMJE guidelines and Good Publishing Practice as well as Good Clinical Practice. Activities • Helped to establish and maintain publication plan for 2 years within the framework of internal and external policies. • Monitored relevant RD, regulatory, legal, IP requirements. • Acted as a focal point for stakeholders on the assigned 10+ projects in Europe and Asia, kept members informed of developments, created issue ownership, and actions taken. • Drafted and critically reviewed documents and presentations (5+ presentations, 2 posters for ASH and ESMO, 5+ clinical articles). • Acquired and maintained literature know-how in the area of cancer vaccine and antigen clinical research and development. • Acted as a company editor, including final QC responsibilities. • Managed the out-contractor relationships (3 writers) to ensure resources with respect to workload. • Build and maintained the internal and external network. • Facilitated consensus between internal and external stakeholders. Projects • ASCI - Antigen-specific cancer immunotherapeutic products. • Pre-clinical, RD, observatory (phase 0) and phase I clinical studies in Europe and Asia with translational endpoints.
CTA / Scientist - Translation Research in Oncology
January 2010 --- January 2011
Lead and coordinated administrative and research activities across oncology-focused research projects including 3 non-interventional phase 0 (translational) clinical trials. • Maintained contact with PIs, researchers, biobank, hospital personnel. • Wrote and critically reviewed weekly reports, protocols, SOPs, guidelines and other documentation related to projects. • Implementated strategy related to biosamples management. • Maintained laboratory protocols and SOPs up-to-date with GLP requirement, 2x year performed internal audits, overseen corrective action implementation. • Trained and supervised laboratory personnel along the projects to asssure appropriate technical knowledge (1 technician and 2 PhD students). • Designed and preformed experiments, analyzed data on a daily basis. • Presented results in front of the international scientific community, collaborators, partners (weekly, F2F/TC). Projects • Identification of new pathways in hematological malignanies using omics methods. • Non-interventional clinical trials aiming to identify and validate new drug targets using gene expression and RNAi profiling, sequencing in patients with colon cancer and in patients with melanoma. • Interferon therapy in JAK1 mutation positive patients with acute lymphoblastic leukemia.
Scientist, Project Leader
September 2005 --- March 2010
Designed and coordinated 7+ international research projects in oncology focused on identification & validation of new biomarkers & drug targets. Activities • Set up and led international multidisciplinary research projects in oncology and immunology with 70% of them leading to publication. • Designed and preformed experiments using tools of molecular biology, genetics, biochemistry, biophysics, structural biology and animal models. • Supervised team of 3 researchers across various projects. • In 3 years, published 7 publications in peer-reviewed journals, 1 journal cover (Haematologica). • Co-inventor of an in vitro diagnostic test (nucleic acid-based). • Wrote and critically reviewed reports, protocols, publications, presentations and other documentation related to projects. • Presented more than 30 oral/poster presentations in front of the scientific community. Projects • Identification of new genetic abnormalitites in kinome of acute lymphoblastic leukemia patients. • Role of interleukine receptors and conformation in oncogenic kinase signaling. • Identification of new therapeutic options for acute lymphoblastic leukemia patients with mutations in JAK kinase. • Identification of JAK kinase mutations resistant to currently available small molecule inhibitors. • Development of in vitro and in vivo models for acute lymphoid leukemia and multiple myeloma. • Role of interleukine-6 and JAK kinase in multiple myeloma proliferation and transformation. • Characterization of IL-22 and IL-28 signaling pathways - common features and differences.
CollaborationCompetitivenessCommunicativeCritical thinkingDiligenceAnalytical thinkingAssertivenessIndependenceKindnessOptimismPerspectiveProblem solvingResult OrientedSelf-confidenceStrategic thinkingTrust
Skills and Expertise
Analytical skills Analyze data Build and manage the Trial Master File (TMF) Create SOPs Design case record forms Develop clinical trial protocols Develop protocols Interact with nurses Interact with physicians Interpret data Monitor a clinical study Search literature on clinical trials Technology research Use content management systems Write papers Write protocolsAct as the main line of communication between the sponsor and the investigatorAdjust processes and methodsAdminister, maintain and co-ordinate the logistical aspects of clinical trialsAdverse event reportingAdvise on strategyArchive documentationArchive study documentsArchive trial documentation and correspondence.Assemble regulatory applicationsAssess business and scientific ethicsAssess product quality issuesAssess quality process issuesAssess site feasibilityassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Assign activitiesAssist with site trainingAttend investigator meetingAttend seminars, courses and meetings within and outside the companyAttend steering committeeBiomarker Researchbudgeting of R&D activitiesCalculate timelines for conducting and completing the trialCapture data on source documentsCell cultureChemistry Manufacturing and Controls (CMC) activitiesClinical data collectionCalculate trial timelinesCoach and provide guidance to clinical staff.collaborate in research projects at universitiesCollaborate with medical teamCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collaborate with principal investigatorCollaborate with project teamCollect financial data from hospitalsCollect patient forms and questionnairesCommunicate effectively on different company levelsCommunicate with investigatorCommunicate with sponsorComplete case report form (CRF)Conduct animal studiesConduct limited data and/or statistical analysis.Conduct literature searchesContribute medical, clinical expertise and scientific advice to all allied departments in local affiliate in particular support to the local clinical development team for timely execution of studies conducted in the affiliate and to DRA in interactions with authorities.control different protocol versions and other essential documentsCoordinate projectscoordinating research projectsCreate clinical project documents according to the protocolCreate SOPsCreate study documentsCreates a collaborative team environmentData codingData entryData miningData validationData verificationDesign case record form (CRF)Design clinical presentationDesign database Design information leafletDesign marketing advertismentsDesign protocolDesign scientific projects (in biology)Design tracking systemDetermine needsDevelop business planDevelop clinical hypothesesDevelop ICH/GCP compliant processesDevelop Quality Risk Management (QRM) initiativesDevelop strong internal relationships with stakeholdersDevelop study budgetDevelop study metricsDevelop study timelinesDevelop training materialsDevelopment of late-stage cGMP production processesDirect co-workers to achieve resultDiscuss treatments with investigatordrafting grant applicationsEnsure data consistencyEnsure data integrityEnsure good clinical practice (GCP)Establish contractsEstablish professional relationships with partnersEstablish relationships with Key Opinion Leaders
Master in Management (former MBA program) in Health Economics from VUB, Solvay Business School in 2013
PhD in Biomedical Sciences and Pharmaceuticals in Oncology, Immunology from UCL, Brussels, Belgium in 2010
Master in Physics in Biophysics and Medicinal Physics from Univerzita 'Pavla Jozefa Šafárika' v Košiciach in 2005
Bachelor in Physics in Theoretical and Mathematical Physics from Univerzita 'Pavla Jozefa Šafárika' v Košiciach in 2003
Bachelor's degree in Communication, Journalism, and Related Programs from Matej Bell University in 1999
Training and Certification
Animal model experimentation - design and supervision (FELASA EU certification C) Certification
Animal model experimentation - GLP (FELASA EU certification B) Certification
Building Authentic Organizations: Key Competencies of Power by Julie Diamond Certification
CRA monitoring training Certification
EU Directives, Regulations and Notification Related to MDD and Cosmetics Certification
EU Regulations Related to Commercialization of Medications Certification
GCP update Certification
Good Clinical Practice Certification
Good Manufacturing Practice Certification
ISO14001 and ISO17025 - Auditor Team Leader Course Certification
Managing Teams Across Borders Certification
Pharmacokinetics and Drug Metabolism Certification
Quality by Design (QbD) and Lifecycle Management for Analytical Methods Certification
Expert has 10 publications (Will be avalible with full profile)