5 дней назад
Clinical Research Assoc Dir (Korea Development Lead)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Clinical Research Assoc Dir (Korea Development Lead) (Clinical Development): Leading end-to-end clinical development strategy and execution in Korea from Phase 1 through lifecycle management with an accent on local regulatory alignment, clinical trial design, and evidence generation. Focus on representing Korea Development in global programs, managing development risks across multiple assets, and translating Korea-specific data gaps into actionable recommendations.
Location: Seoul, South Korea
Company
develops biopharmaceutical products and clinical programs.
What you will do
- Lead Korea-specific clinical development strategies and plans from Phase 1 through lifecycle management.
- Represent Korea Development in interactions with health authorities and external stakeholders.
- Translate Korea-specific data gaps and insights into recommendations for global programs.
- Partner with Regulatory, Clinical Operations, Safety, Medical Affairs, and other functions to deliver compliant development activities.
- Assess development risks, feasibility, prioritization, and resource allocation across multiple assets.
- Set annual Korea clinical development strategies and clinical trial goals.
Requirements
- Medical Doctor or Ph.D.
- At least five years of clinical research and/or basic science research experience.
- Clinical research experience in the biopharmaceutical industry, including biotech, pharmaceutical, or CRO organizations.
- In-depth knowledge of clinical trial design and execution, scientific and clinical judgment, and the relevant therapeutic area.
- Understanding of Korea regulatory agency requirements, guidelines, and practices, as well as Good Clinical Practices and applicable international regulations.
- Strong strategic thinking, risk-based problem solving, communication, influencing, and cross-functional collaboration skills.
Nice to have
- MD or Ph.D. with accredited residency in a relevant subspecialty and board certification or equivalent.
- Eight or more years of combined clinical research, basic science research, clinical teaching, and patient care experience.
- Previous management experience.
Culture & Benefits
- Cross-functional and cross-cultural collaboration across Korea and global development programs.
- Opportunity to influence global clinical development strategy through Korea-specific insights.
- Accountability for high-quality, timely, and compliant clinical development delivery.
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