Clinical Research Associate Director - Korea Development Lead

About the role

Amgen is looking for a Clinical Research Associate Director (Korea Development Lead) who will own end-to-end clinical development strategy and execution in Korea across assigned development teams. As the primary development representative for the team, the role ensures that development decisions and execution in Korea meet local regulatory and practice needs, and is accountable for the quality, timeliness and compliance of Korea development programs.

Key responsibilities

• Lead the development and execution of Korea-specific clinical development strategies and plans from Phase 1 through lifecycle management, aligned with global program strategy and evidence generation objectives.
• Act as the Korea Development TA representative with health authorities and key external stakeholders, turning Korea-specific data gaps and insights into actionable development recommendations for global programs.
• Represent Korea Development in global programs, deciding on key goals, milestones, options and trade-offs with scientific and strategic input.
• Partner with Regulatory, Clinical Operations, Safety, Medical Affairs and others to ensure integrated, compliant and high-quality execution.
• Assess and manage Korea-specific development risks and feasibility, and prioritize resources across multiple assets.
• Deliver yearly Korea clinical development strategies and trial goals, and provide high-quality input that meets local health authority needs and influences global deliverables.

Required profile

• Medical doctor or Ph.D.
• Five or more years of clinical research experience and/or basic science research experience; preferred: eight or more years including clinical teaching and patient care, and previous management experience.
• Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO).
• Preferred: MD or Ph.D. plus accredited residency in a relevant sub-specialty, board certified or equivalent.

Required skills

• In-depth understanding of the scientific method and complex clinical trial design and conduct.
• Medical knowledge in the relevant therapeutic area and sound scientific and clinical judgment.
• Knowledge of Korea regulatory requirements, guidelines and practices, and of Good Clinical Practice (GCP) and international regulatory requirements.
• Understanding of new drug commercialization and business practices.
• Strategic thinking, risk-based problem solving, matrix leadership, cross-functional collaboration and clear communication of complex development topics.