John Choi
North Brunswick,USA
Summary
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
Overview
33
33
years of professional experience
Work History
Executive Clinical Advisor
WMSG (W Medical Strategy Group)
04.2023 - Current
- Responsible 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 clients
- Responsible for SSU activities including site identification for Drug/Device clients
- Responsible for regulatory and clinical business development opportunities at clinical meetings/forums/conferences and client meetings
- Responsible for project management and in-house clinical trial management for Cataract Surgery Device Performance Study
- Responsible for Drug/Device protocol/ICF writings and CRF design
- Responsible for Drug/Device Advarra IRB and FDA IND and IDE submissions.
Executive Director of Clinical Services
Target Health, LLC (CRO)
07.2022 - 03.2023
- Oversee all clinical and device services and projects including budget management and forecasting
- Responsible for proposal writings and vendor(sites) contracts
- Lead medical (protocol and ICF) writings
- Lead all proposal defense meetings
- Responsible for clients’ clinical and regulatory strategies for drugs (P1, P2) and devices (IVD, SaMD, etc.)
Executive Director and Head of Clinical Operations
Enzychem Lifesciences
04.2018 - 06.2022
- Clinical Development – Task Force Head, responsible for the on-going and future corporate clinical deliverables planning, management and strategies
- Oversee Phase 2 US clinical trials (LASCC H&N, COVID-19) project management and clinical operations activities
- Responsible for clinical trials and vendor budget management
- Responsible for managing all vendors including CMC, Medical and Regulatory Consultants, CROs, Central Lab, IP Transport Services and all vendor proposals/invoices
- Responsible for the contract resource management
- Implement resource strategies to achieve project goals
- Lead essential documents writings including clinical protocols, investigator’s brochures, ICF and CSR writings
- Lead Pre-INDs, INDs and EOP2 Meeting preparation
- Responsible for US clinical resources
- Responsible for site and other vendor contracts negotiation and execution.
Project Manager, Oncology Clinical Protocol Operations (8 month contract)
Bristol-Myers Squibb
07.2017 - 03.2018
- Oversee three interdisciplinary clinical research programs (Immune Checkpoint Inhibitors: Checkmates)
- Lead clinical team to ensure quality, timelines, and budget management
- Accountable for the financial performance of each project assignment
- Coordinate activities and deliverables of the assigned study conduct partners and proactively identify and manage issues
- Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements
- Responsible for study management components of inspection readiness for all aspects of the study conduct
- Plan, coordinate, and present at internal and external meetings.
President
Piscium International, Inc. (Clinical Consulting)
09.2014 - 05.2017
- Review and recommend CRO RFPs and budget negotiations for Korean pharmaceutical companies
- Review and recommend sites negotiation and contracts
- Advise on currently running clinical trials’ critical paths and cost, time, and resource constraints
- Strategize APAC countries’ regulatory issues and challenges
- Perform APAC site feasibilities, PSSVs, and SIVs
- Project manage ongoing clinical trials.
Head and Director of Clinical Operations APAC and TS3 APAC/Country Head Korea
Theorem Clinical Research (Chiltern, Now Covance)
05.2013 - 08.2014
- Accountable for Korea and other APAC countries’ P&L
- Create business development plans for new opportunities in APAC
- Lead regional triage meetings for country assignment, performance, and resource load balancing
- Facilitate and lead APAC Bid Defense preps and meetings
- Manage APAC day-to-day clinical operations including project and line management responsibilities
- Manage regional project budget including COs, forecasting and margin evaluations
- Client Relationship Management for Clinical Operations and FSP
- Lead regional cross-functional projects
- Develop RFP responses and budget proposals.
Chief Executive Officer
Solomon Medical Research (CRO)
02.2010 - 04.2013
- Expanded internal resources to 14 CRAs, PMs, and DMs
- Create and lead business development opportunities
- Lead Korea project management activities
- Lead Pre-Clinical consulting services
- Author/Review/Approve KFDA (MFDS) IND submission dossier
- Develop RFPs and budget proposals
- Lead sites negotiation and contracts
- P&L responsibilities
- Facilitate and lead Bid Defense preps and meetings
- 3 years as a lecturer to School of Nursing Graduate students and Clinical Operations professional.
Resource Manager, Global Clinical Operations
Bristol Myers Squibb
01.2006 - 12.2009
- Managed global clinical resource utilization and balance loading for ID/IMM/MET/CV/NS departments
- Responsible for capacity planning and forecasting for non-clinical/clinical divisions.
Experienced Senior Manager, Clinical Consulting
Barnett International
09.2000 - 12.2005
- Re-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 utilization
- Managed resource planning for (Medical Directors, PK Scientists, Clinical Pharmacologists, Early Discovery, Worldwide Clinical PMs, CTMs and CRAs)
- Lead technical architecture solution delivery projects.
Experienced Manager, Pharmaceutical Consulting Division
Accenture
09.1991 - 08.2000
- Project Lead Bristol Myers Squibb IMPACT CTMS implementation
- Installation and Integration with other systems
- Management of contract programmers, Accenture programmers and analysts
- Project Lead Astra Zeneca CTX to IMPACT CTMS conversion
- Project Lead IMPACT CTMS implementation
- Development of home grown CTX (Clinical Trial eXecution), Safety and Clinical Supplies Management System
- Lead Technical Architect in delivering AS-IS and TO-BE processes, data information and applications at Johnson & Johnson
- Project Lead Wyeth Ayerst Faster Application Submission Time (FAST) technical team in developing Image Scanning Status Tracking System, Global Library Viewer, and Work Flow System.
Education
Master of Science - Computer Engineering
Boston University
Boston, MA05.1987
Bachelor of Science - Computer Engineering (Completed 3 yrs Chemistry/Biology Pre-Med)
Boston University
Boston, MA05.1983
Skills
- Medical Writing (Protocol, ICF) & CRF Design & Supervision
- Central IRB (WIRB) and Advarra IRB Management
- Drugs and Devices Clinical Trials Operations and Management from Start-Up to Close-outs
- CRO, Sites, and Other Vendors Contracts
- Project & People Management
- ICH-GCP Guidelines Knowledge
- DSMB Management
- Clinical Monitoring
- Site Management
- SOP Management
- Communication & Leadership Skills
- Data Management & Analyses
- Electronic Data Capture and Management Systems
- Relationship Building & Teamwork
- Creative Problem-Solving
- Proactive & Adaptable
- Microsoft Office & Google Suite
Languages
Korean
Native or Bilingual
Timeline
Executive Clinical Advisor
WMSG (W Medical Strategy Group)
04.2023 - Current
Executive Director of Clinical Services
Target Health, LLC (CRO)
07.2022 - 03.2023
Executive Director and Head of Clinical Operations
Enzychem Lifesciences
04.2018 - 06.2022
Project Manager, Oncology Clinical Protocol Operations (8 month contract)
Bristol-Myers Squibb
07.2017 - 03.2018
President
Piscium International, Inc. (Clinical Consulting)
09.2014 - 05.2017
Head and Director of Clinical Operations APAC and TS3 APAC/Country Head Korea
Theorem Clinical Research (Chiltern, Now Covance)
05.2013 - 08.2014
Chief Executive Officer
Solomon Medical Research (CRO)
02.2010 - 04.2013
Resource Manager, Global Clinical Operations
Bristol Myers Squibb
01.2006 - 12.2009
Experienced Senior Manager, Clinical Consulting
Barnett International
09.2000 - 12.2005
Experienced Manager, Pharmaceutical Consulting Division
Accenture
09.1991 - 08.2000
Master of Science - Computer Engineering
Boston University
Bachelor of Science - Computer Engineering (Completed 3 yrs Chemistry/Biology Pre-Med)
Boston University
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