Clinical Research Assoc Dir

Job description

Career Category Clinical

Job Description

Clinical Research Assoc Dir (Korea Development Lead)

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
• 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 .