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Click here or scroll down to respond to this candidateCandidate's Name
Street Address USAPHONE NUMBER AVAILABLEEMAIL AVAILABLEWEBSITELINKEDIN LINK AVAILABLEPROFESSIONAL SUMMARYI am seeking a clinical operations management position providing over 32 years of pharmaceutical industry experience centered in clinical operations management including P&L, project planning and resource management, regulatory services, training, business process and clinical development improvement, device and drug clinical trial management, medical device approvals, and quality assurance including SOP management.PROFESSIONAL SKILLSMedical Writing (Protocol, ICF) & CRF Design & SupervisionCentral IRB (WIRB) and Advarra IRB ManagementDrugs and Devices Clinical Trials Operations and Management from Start-Up to Close-outsCRO, Sites, and Other Vendors ContractsProject & People ManagementICH-GCP Guidelines KnowledgeDSMB ManagementClinical MonitoringSite ManagementSOP ManagementCommunication & Leadership SkillsData Management & AnalysesCreating Problem-SolvingRelationship Building & TeamworkMicrosoft Office & Google SuiteProactive & AdaptableWORK HISTORYEXECUTIVE CLINICAL ADVISOR04/2023 to CURRENTWMSG (W Medical Strategy Group) Englewood Cliffs, NJResponsible for regulatory and clinical strategy for pivotal device studies (510K, de novo, PMA)Responsible for proposal writing including budget creation and site negotiation/contracts for Drug/Device clientsResponsible for SSU activities including site identification for Drug/Device clientsResponsible for regulatory and clinical business development opportunities at clinical meetings/forums/conferences and client meetingsResponsible for project management and in-house clinical trial management for Cataract Surgery Device Performance StudyResponsible for Drug/Device protocol/ICF writings and CRF designResponsible for Drug/Device Advarra IRB and FDA IND and IDE submissionsEXECUTIVE DIRECTOR OF CLINICAL SERVICES07/2022 to 03/2023Target Health, LLC (CRO) Carlstadt, NJOversee all clinical and device services and projects including budget managementResponsible for proposal writings and vendor(sites) contractsLead medical (protocol and ICF) writingsResponsible for clients' clinical and regulatory strategies for drugs (P1, P2) and devices (IVD, SaMD, etc.)EXECUTIVE DIRECTOR AND HEAD OF CLINICAL OPERATIONS04/2018 to 06/2022Enzychem Lifesciences Englewood Cliffs, NJClinical Development Task Force Co-Head, responsible for the ongoing and future corporate clinical deliverables planning, management, and strategiesOversee Phase 2 US clinical trials (LASCC H&N, COVID-19) project management and clinical operations activitiesResponsible for clinical trials and vendor budget managementResponsible for the contract resource managementImplement resource strategies to achieve project goalsLead essential documents writings including clinical protocols and ICF writingsLead Pre-INDs and INDsResponsible for US clinical resourcesResponsible for site and other vendor contracts negotiation and executionPROJECT MANAGER, ONCOLOGY CLINICAL PROTOCOL OPERATIONS (FSP CONTRACT)07/2017 to 03/2018Bristol-Myers Squibb Lawrenceville, NJOversee three interdisciplinary clinical research programs (Immune Checkpoint Inhibitors: Checkmates)Lead clinical team to ensure quality, timelines, and budget managementAccountable for the financial performance of each project assignmentCoordinate activities and deliverables of the assigned study conduct partners and proactively identify and manage issuesEnsure studies are conducted in compliance with GCP, relevant SOP's and regulatory requirementsResponsible for study management components of inspection readiness for all aspects of the study conductPlan, coordinate, and present at internal and external meetingsPRESIDENT09/2014 to 05/2017Piscium International, Inc. (Clinical Consulting) Seoul, KoreaReview and recommend CRO RFPs and budget negotiations for Korean pharmaceutical companiesReview and recommend site(s) negotiation and contractsAdvise on currently running clinical trials' critical paths and cost, time, and resource constraintsStrategize APAC countries' regulatory issues and challengesPerform APAC site feasibilities, PSSVs, and SIVsProject manage ongoing clinical trialsHEAD AND DIRECTOR OF CLINICAL OPERATIONS APAC AND TS3 APAC/COUNTRY HEAD KOREA05/2013 to 08/2014Theorem Clinical Research (Chiltern, Now Covance) Seoul, KoreaAccountable for Korea and other APAC countries' P&LCreate business development plans for new opportunities in APACLead regional triage meetings for country assignment, performance, and resource load balancingFacilitate and lead APAC Bid Defense preps and meetingsManage APAC day-to-day clinical operations including project and line management responsibilitiesManage regional project budget including COs, forecasting and margin evaluationsClient Relationship Management for Clinical Operations and FSPLead regional cross-functional projectsDevelop RFP responses and budget proposalsCHIEF EXECUTIVE OFFICER02/2010 to 04/2013Solomon Medical Research (CRO) Seoul, KoreaExpanded internal resources to 14 CRAs, PMs, and DMsCreate and lead business development opportunitiesLead Korea project management activitiesLead Pre-Clinical consulting servicesAuthor/Review/Approve KFDA (MFDS) IND submission dossierDevelop RFPs and budget proposalsLead site(s) negotiation and contractsP&L responsibilitiesFacilitate and lead Bid Defense preps and meetings3 years as a lecturer to School of Nursing Graduate students and Clinical Operations professionalRESOURCE MANAGER, GLOBAL CLINICAL OPERATIONS01/2006 to 12/2009Bristol Myers Squibb Lawrenceville, NJManaged global clinical resource utilization and balance loading for ID/IMM/MET/CV/NS departmentsResponsible for capacity planning and forecasting for non-clinical/clinical divisionsEXPERIENCED SENIOR MANAGER, CLINICAL CONSULTING09/2000 to 12/2005Barnett International Media, PARe-design and Optimize clinical development processes as technical architect to (Centocor, MedImmune, Cephalon)Capacity Planning and Forecasting advisor to Merck (MRL in Upper Gwynedd, PA)Developed Clinical Time Tracking System to track/forecast project resources and utilizationManaged resource planning for (Medical Directors, PK Scientists, Clinical Pharmacologists, Early Discovery, Worldwide Clinical PMs, CTMs and CRAs)Lead technical architecture solution delivery projectsEXPERIENCED MANAGER, PHARMACEUTICAL CONSULTING DIVISION 09/1991 to 08/2000Accenture Philadelphia, PAProject Lead Bristol Myers Squibb IMPACT CTMS implementationInstallation and Integration with other systemsManagement of contract programmers, Accenture programmers and analystsProject Lead Astra Zeneca CTX to IMPACT CTMS conversionProject Lead IMPACT CTMS implementationDevelopment of home grown CTX (Clinical Trial eXecution), Safety and Clinical Supplies Management SystemLead Technical Architect in delivering AS-IS and TO-BE processes, data information and applications at Johnson & JohnsonProject Lead Wyeth Ayerst Faster Application Submission Time (FAST) technical team in developing Image Scanning Status Tracking System, Global Library Viewer, and Work Flow SystemSUMMARY OF MAJOR PROJECT EXPERIENCETherapeutic Area, Sub-Indicationand Drug ClassPhaseJob TitleCataract Surgery with and without illuminating chopperDevice TrialExec DirectorCRIOM (Chemoradiation Induced OM)IIExec DirectorCOVID-19 Mild/Moderate Pneumonia in USIIExec DirectorClassical Hodgkin LymphomaI/IIProtocol ManagerMetastatic Colorectal CarcinomaIIIDirectorDose escalation for advanced refractory solid tumorsIDirectorType2 diabetes mellitusIIIDirectorSafety and efficacy of a netupitant-palonosetron fixed dose combinationIIIDirectorTreatment for sudden hearing lossIIDirectorTreatment for staphylococcus aureus bacteremiaIIIDirector2 NSCLC studies (immunotherapy (ICI))IIIProtocol ManagerRespiratory/CAPII, IIISr Project MgrCardiovascular disease prophylaxis/Muscle PainIISr Project MgrAnti-Inflammatory/NSAIDSII, IIISr Project MgrAnti-Cancer SupplementIISr Project MgrSYSTEM AND VENDOR EXPERIENCETypeNameContract Research OrganizationPRA, ICON, COVANCE, PPD, SYNEOS, Medpace, Theorem, ARG, Target Health, BarnettRegulatory ServicesKinexum, CSI, Esphalion, Target HealthIXRSBioclinica, ClinphoneCTMSIMPACT, Siebel, Bioclinica, ClinphoneCDMS, EDCOracle Clinical, Siebel, Medidata RAVE, Datalabs, Medrio, ClinTrakeTMFeTMF, Veeva, PhlexEviewEDUCATIONMaster of Science Computer Engineering 05/1987Boston University, Boston, MABachelor of Science Computer Engineering (Completed 3 yrs Chemistry/Biology Pre-Med) 05/1983Boston University, Boston, MALANGUAGESKoreanNative or Bilingual. |
