Clinical Operations Management
Resume:
John H Choi
*** **** *****, ***** *********, NJ *8902 USA
******@*****.***
WEBSITE
linkedin.com/in/john-choi-9202166
PROFESSIONAL SUMMARY
I 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 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
Creating Problem-Solving
Relationship Building & Teamwork
Microsoft Office & Google Suite
Proactive & Adaptable
WORK HISTORY
EXECUTIVE CLINICAL ADVISOR
04/2023 to CURRENT
WMSG (W Medical Strategy Group) Englewood Cliffs, NJ
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
07/2022 to 03/2023
Target Health, LLC (CRO) Carlstadt, NJ
Oversee all clinical and device services and projects including budget management
Responsible for proposal writings and vendor(sites) contracts
Lead medical (protocol and ICF) writings
Responsible for clients' clinical and regulatory strategies for drugs (P1, P2) and devices (IVD, SaMD, etc.)
EXECUTIVE DIRECTOR AND HEAD OF CLINICAL OPERATIONS
04/2018 to 06/2022
Enzychem Lifesciences Englewood Cliffs, NJ
Clinical Development – Task Force Co-Head, responsible for the ongoing 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 the contract resource management
Implement resource strategies to achieve project goals
Lead essential documents writings including clinical protocols and ICF writings
Lead Pre-INDs and INDs
Responsible for US clinical resources
Responsible for site and other vendor contracts negotiation and execution
PROJECT MANAGER, ONCOLOGY CLINICAL PROTOCOL OPERATIONS (FSP CONTRACT)
07/2017 to 03/2018
Bristol-Myers Squibb Lawrenceville, NJ
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
09/2014 to 05/2017
Piscium International, Inc. (Clinical Consulting) Seoul, Korea
Review and recommend CRO RFPs and budget negotiations for Korean pharmaceutical companies
Review and recommend site(s) 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
05/2013 to 08/2014
Theorem Clinical Research (Chiltern, Now Covance) Seoul, Korea
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
02/2010 to 04/2013
Solomon Medical Research (CRO) Seoul, Korea
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 site(s) 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
01/2006 to 12/2009
Bristol Myers Squibb Lawrenceville, NJ
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
09/2000 to 12/2005
Barnett International Media, PA
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 09/1991 to 08/2000
Accenture Philadelphia, PA
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
SUMMARY OF MAJOR PROJECT EXPERIENCE
Therapeutic Area, Sub-Indication
and Drug Class
Phase
Job Title
Cataract Surgery with and without illuminating chopper
Device Trial
Exec Director
CRIOM (Chemoradiation Induced OM)
II
Exec Director
COVID-19 Mild/Moderate Pneumonia in US
II
Exec Director
Classical Hodgkin Lymphoma
I/II
Protocol Manager
Metastatic Colorectal Carcinoma
III
Director
Dose escalation for advanced refractory solid tumors
I
Director
Type2 diabetes mellitus
III
Director
Safety and efficacy of a netupitant-palonosetron fixed dose combination
III
Director
Treatment for sudden hearing loss
II
Director
Treatment for staphylococcus aureus bacteremia
III
Director
2 NSCLC studies (immunotherapy (ICI))
III
Protocol Manager
Respiratory/CAP
II, III
Sr Project Mgr
Cardiovascular disease prophylaxis/Muscle Pain
II
Sr Project Mgr
Anti-Inflammatory/NSAIDS
II, III
Sr Project Mgr
Anti-Cancer Supplement
II
Sr Project Mgr
SYSTEM AND VENDOR EXPERIENCE
Type
Name
Contract Research Organization
PRA, ICON, COVANCE, PPD, SYNEOS, Medpace, Theorem, ARG, Target Health, Barnett
Regulatory Services
Kinexum, CSI, Esphalion, Target Health
IXRS
Bioclinica, Clinphone
CTMS
IMPACT, Siebel, Bioclinica, Clinphone
CDMS, EDC
Oracle Clinical, Siebel, Medidata RAVE, Datalabs, Medrio, ClinTrak
eTMF
eTMF, Veeva, PhlexEview
EDUCATION
Master of Science Computer Engineering 05/1987
Boston University, Boston, MA
Bachelor of Science Computer Engineering (Completed 3 yrs Chemistry/Biology Pre-Med) 05/1983
Boston University, Boston, MA
LANGUAGES
Korean
Native or Bilingual
.
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