Clinical Research Assoc Dir

Clinical Research Assoc Dir

Accountabilities

• End-to-end accountability for clinical development strategy and execution in Korea across assigned development TAs
• Serves as the primary Development representative for TA, ensures that development decisions and execution in Korea are fit-for-purpose for local regulatory and practise, and be accountable for the quality, timeliness, and compliance of Korea development programs

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.

• Serve as the Korea Development TA representative in interactions with health authorities and key external stakeholders, and translate Korea-specific data gaps and insights into actionable development recommendations for global programs

• Represent Korea Development in global program, decide on key Korea development goals, milestones, options, and trade-offs with scientific and strategic input to ensure relevance and feasibility for Korea.

• Partner cross-functionally with Regulatory, Clinical Operations, Safety, Medical Affairs, and other stakeholders to ensure integrated, compliant, and high-quality execution of Korea development activities.

• Assess and manage Korea-specific development risks, feasibility considerations, and prioritization across multiple assets, guiding resource focus based on strategic value and execution readiness.

• Outputs

• Setting up yearly Korea clinical development strategies and clinical trial goal

• Successful and compliant delivery of Korea clinical development activities.

• High‑quality Korea development input that meets local health authority need and also influences global development deliverable

Qualifications

• Basic Qualifications

• Medical Doctor or Ph.D.

• Five (5) or more years of clinical research experience and/or basic science research experience

• Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)

• Preferred Qualifications

• MD or Ph.D plus accredited residency in relevant sub-specialty, board certified or equivalent

• Eight (8) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities

• Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)

• Previous management experience

• Knowledge

• In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale

• In-depth understanding of and proven success in how to conceptualize, design, and conduct complex clinical trials

• Medical knowledge in the relevant therapeutic area

• Sound scientific and clinical judgment

• Understanding of Korea regulatory agency requirement, guidelines, and practices and ability to negotiate with these groups

• Knowledge of Good Clinical Practices (GCP), and applicable international regulatory requirements

• Understanding of new drug commercialization and business practices

• Competencies

• Scientific and clinical judgment in development decision-making

• Strategic thinking and risk-based problem solving

• Shape vision, Matrix leadership and influencing skills

• Cross-functional and cross-cultural collaboration

• Clear and effective communication of complex development topics

• Accountability and ownership mindset aligned with Amgen values