Clinical Research Assoc Dir
Amgen · Seoul, South Korea
Clinical OperationsFull-timeCompany career page
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Role summary
Amgen seeks a Clinical Research Associate Director to lead end-to-end clinical development strategy and execution in Korea. The role involves managing development programs across therapeutic areas, serving as the primary liaison with Korean health authorities, and ensuring alignment with global clinical strategies while meeting local regulatory requirements.
What they're looking for
- MD or Ph.D. degree
- Five or more years of clinical research experience in biopharmaceutical industry
- In-depth knowledge of clinical trial design, GCP, and regulatory requirements
- Understanding of Korean regulatory agency requirements and negotiation ability
- Strong scientific and clinical judgment with strategic thinking capability
- Cross-functional leadership and cross-cultural collaboration skills
What you'll be doing
- Develop and execute Korea-specific clinical development strategies aligned with global programs and evidence generation objectives
- Serve as Korea development representative in interactions with health authorities and external stakeholders
- Represent Korea development in global programs, determining key development goals, milestones, and trade-offs
- Partner cross-functionally with regulatory, clinical operations, safety, and medical affairs teams to ensure compliant execution
- Assess and manage Korea-specific development risks, feasibility, and resource prioritization across multiple assets
Privacy & handoff
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