Clinical Study Director Paris, France
Since July 2017
Early phase (large molecule, FIH), oncology, hematology, rare disease project leading.
Medical director, General director deputy (VP) in clinical research
March 2015 --- December 2016
As the Medical Director, Valery is responsible for providing medical direction to clinical studies in Oncology and contributing towards execution of company’s clinical development programs spanning drug development plan and protocols writing until final report and state authority’s registration in several countries. Being a member of the clinical project team, Valery is leading medical department teams across more than 20 projects at present along with continuously educating them in project specific topics. Also, Valery is involved in the analysis and interpretation of clinical trial data and reporting of clinical trial results. He provides clinical support to the management team in its communications with the Board of Directors, investors, and potential business partners. Along with engaging in scientific interactions, he fosters fruitful relationships with opinion leaders. Furthermore, he reviews current trials consisting DM data, protocol deviations, and basic KPIs such as sites activation, patients’ recruitment and timelines. In order to ensure the overall performance is in line with expectations, he conducts audits. Some of the highlights of this role include: • Effectively led and grew the team from 7 to 50+ persons in 1 year serving in various clinical trials conduct including data management, medical writing, statistical, full clinical operations team, QA, etc. • Gained success in securing recruitment and timelines through effective selection of sites for clinical trials that under risk due to time constrains. • Initiated 2 oncological phase III trials in 2015 (25 and 30 sites) and 3 smaller trials, inclusive one of phase I in healthy volunteers.
Director of Operations
August 2014 --- February 2015
Setup and maintenance of clinical and business operations in Eastern Europe
Regional Director of clinical operations (Russia, Ukraine, Belarus, Georgia, Kazakhstan)
October 2003 --- March 2013
In his role as Senior Director, Valery led a clinical operations team and multifunctional teams across Russia, Ukraine, Belarus, Kazakhstan and Georgia with focus on regulatory and safety submission, Study start up, critical milestones setup, observation of timely deliverables, critical issues handling in several countries of region, Clinical Monitoring, and much more. Other responsibilities in this role included: reviewing documents required for clinical trials, hiring and training of clinical operations staff and administrative staff, budgeting, P&L management & expenses control, Vendor Management and quality assurance. Valery represented the region in central proposal input and bid defense and acted as legal representative in Russia, Ukraine and in Georgia and supported and facilitated QA, sponsor, HAs and independent entities during audits. Team has grown from 10+ till 100+ employees.
Partner, Managing director and Head of Moscow representation
August 2000 --- September 2003
Set up of operations in Russia, Ukraine and Belarus from ground level until fully operating company. Financial planning for business unit and company. Supervising, training and setting up of monitoring, regulatory and legal teams. Business development: contacts to clients, study and study budget planning, pass-through costs estimation; negotiation of agreements with client. Company was acquired by PRA International as base for activities in region.
March 1993 --- March 1998
Country team lead
January 1997 --- January 1998
Clinical Research Associate (CRA)
January 1994 --- January 1997
September 1991 --- March 1993
AdaptabilityAnalytical thinkingAssertivenessAttention to detailCollaborationCommunicativeCompetitivenessCoordinationCritical thinkingCreative thinkingCuriosityDiligenceFlexibilityInnovative thinkingInterest in knowledgeOptimismOrganizationPerspectiveProactivityProblem solvingResponsibilityResult OrientedSelf-disciplineService orientedStrategic thinking
Negotiation Phase I R&D Scientific writing21 CFR Part 11Adverse Events (AE)Allergy and immunologyAntibodiesBiological Drug DevelopmentBudget ManagementBudget NegotiationBudget ProcessBudgetingBudgetsBusiness DevelopmentBusiness IntelligenceBusiness PlanningBusiness ProcessBusiness Process ImprovementBusiness ProcessesBusiness StrategyCancerCancer ResearchCAPACardiovascular diseasescGMPChange ControlChange ManagementClinical Data ManagementClinical DevelopmentClinical monitoringClinical operationsClinical researchClinical Study DesignClinical study reportsClinical trial audits and inspectionsClinical trial budgetingClinical trial designClinical trial managementClinical Trial Management System (CTMS)CROCross-functional team leadershipCRF designData cleaningData AnalysisData ManagementEarly development stageeCRFeCTDEDCGood Clinical Practice (GCP)HematologyLeadershipOncology Clinical ResearchOperations ManagementPhase IPhase IIPhase IIIPhase IVPhases of clinical development (phase I to IV)
Skills and Expertise
Analytical skills Analyze data Build and manage the Trial Master File (TMF) Build the CMC development plan Control data Create SOPs Design case record forms Develop clinical trial protocols Develop protocols Interact with physicians Interpret data Monitor a clinical study Report data Search literature on clinical trials Write protocols Write papersAdverse event reportingAdvise on medical perspectivesAdvise on strategyAlzheimerAdminister, maintain and co-ordinate the logistical aspects of clinical trialsApprove monitoring reportsAssess site feasibilityAssess quality process issuesAttend at steering committee meetingsAttend investigator meetingAttend steering committeeBiomarker Researchbudgeting of R&D activitiesBuild trial master file (TMF)Coach clinical staffCoach staffCoach and provide guidance to clinical staff.CoachCollaborate with medical teamPeople managementPlanning clinical studiesproject managementR&D
Ph.D. in Clinical Research in onclolgy from Blokhin Cancer Research Center in 1997
Post Graduate in hematology from Hematological science research center in 1993
M.D. in General Medicine from First Moscow State Medical University named after I.M. Sechenov in 1991
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Training and Certification
Managing Project Budgets Certification
Managing Project Schedules Certification