Yoonyeong Lee
New York,NY
Summary
With extensive experiences in steering clinical development, including pivotal contributions to COVID-19 vaccine development, I excel in leading project teams through challenging timelines and budget constraints. A people-oriented leader, I cultivate positive team cultures, monitor performance, and drive innovation for adaptive responses. Beyond my organizational roles, active engagement in clinical advisory boards and voluntary networks showcases my industry influence, complemented by ongoing academic development in social pharmacology expertise.
Overview
11
11
years of professional experience
Work History
Team Leader
SK bioscience
Seoul, Republic of Korea
12.2021 - 11.2023
- Coordinated team activities and delegated tasks to streamline the execution of clinical research projects.
- Cultivated positive teamwork and relationships through proactive communication, training initiative, and development coaching.
- Collaborated with team members to set clear objectives, monitor performance, and conduct evaluations for team success.
- Oversaw workflow to ensure strict adherence to established policies and procedures, including monitoring project schedules to motivate the team to meet deadlines within budget constraints.
- Developed strategies for effective problem-solving and conflict resolution.
- Fostered collaboration across departments and with external stakeholders, ensuring a cohesive alignment of goals.
Project Manager
SK bioscience
Seoul, Republic of Korea
07.2018 - 11.2021
- Orchestrated the execution of multi-regional clinical studies, overseeing the entire lifecycle from setup, including IND submission, to closeout.
- Directed medical writing for critical documents and collaborated for scientific communication standards and regulatory compliance.
- Played a key role in audits and inspections for product licenses, reviewing CTD and study reports with a clinical focus.
- Proactively led project members, providing training, mentoring, and bridging within the team.
- Oversaw CRO and other stakeholders, ensuring project alignment in budget, quality, and timeline.
- Collaborated with senior management on strategic planning for development and execution stages, contributing to cross-functional teams for clinical advancements.
Clinical Research Manager
SK chemicals
Seoul, Republic of Korea
04.2016 - 06.2018
- Oversaw comprehensive project management, covering planning, execution, and closure of clinical studies, culminating in NDA/BLA submission.
- Ensured the quality of clinical studies to meet ICH-GCP and relevant regulations.
- Developed and implemented clinical research protocols, consent forms, case report forms, and other study documents.
- Implemented risk management plans to identify potential risks associated with clinical trials.
- Monitored clinical study progress in adherence to established timelines and budgets.
- Managed the CRO, venders, and stakeholders to ensure alignment with project goals.
Pharmacovigilance Associate
SK chemicals
Seoul, Republic of Korea
10.2012 - 12.2013
- Assessed adverse drug reaction reports from healthcare professionals and patients to determine causality.
- Collaborated with internal teams to ensure the prompt completion of safety data collection activities.
- Formulated standard operating procedures concerning the collection and reporting of safety data.
- Produced comprehensive reports that analyzed post-marketing surveillance data gathered from various sources.
- Provided guidance on the development of pharmacovigilance plans and strategies.
- Crafted written summaries detailing findings from pharmacovigilance investigations for regulatory submission purposes.
Regulatory Affairs Associate
Lundbeck Korea
Seoul, Republic of Korea
07.2012 - 10.2012
- Conducted thorough reviews and evaluations of regulatory documents to ensure compliance with applicable regulations.
- Developed submissions for new product applications in adherence to relevant international standards.
- Aided in the preparation of responses to inquiries from global health authorities regarding regulatory matters.
- Collaborated with regional regulatory affairs manager in general regulatory communications and drug price negotiation.
- Formulated standard operating procedures related to regulatory processes.
- Executed customs clearance responsibilities in the role of import and export manager
Education
Ph.D. Candidate - Social Pharmacy
Seoul National University
Seoul, Republic Of Korea08.2022
Master of Pharmacy - Pharmaceutical Sciences
Seoul National University
Seoul, Republic Of Korea08.2012
Bachelor of Manufacturing Pharmacy - Pharmaceutical Sciences
Seoul National Univerisy
Seoul, Republic Of Korea02.2010
Skills
- Clinical Research Project Management
- Cross-Functional Team Management
- People Management
- Leadership, Coaching, and Mentoring
- Strategic Planning
- Performance Improvements
- Quality Assurance
- Data Management
- Statistic Analysis
- Pharmacovigilance
Languages
English
Professional
Korean
Native/ Bilingual
Timeline
Team Leader
SK bioscience
12.2021 - 11.2023
Project Manager
SK bioscience
07.2018 - 11.2021
Clinical Research Manager
SK chemicals
04.2016 - 06.2018
Pharmacovigilance Associate
SK chemicals
10.2012 - 12.2013
Regulatory Affairs Associate
Lundbeck Korea
07.2012 - 10.2012
Ph.D. Candidate - Social Pharmacy
Seoul National University
Master of Pharmacy - Pharmaceutical Sciences
Seoul National University
Bachelor of Manufacturing Pharmacy - Pharmaceutical Sciences
Seoul National Univerisy
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