Clinical Development Leader

About the Company

Our client is a leading global biopharmaceutical organization dedicated to discovering and delivering innovative medicines that address serious diseases. With a strong pipeline and global footprint, the company is at the forefront of scientific advancement, particularly in oncology and specialty care.

The Opportunity

We are seeking a highly experienced Clinical Development Leader to join a high-performing global clinical team. This role will play a critical part in driving clinical strategy and execution, particularly within oncology, while serving as a key interface with Japanese regulatory authorities.

This is an excellent opportunity for a clinical expert with PMDA consultation experience who is passionate about advancing innovative therapies and shaping development strategies in Japan and globally.

Key Responsibilities

• Lead the development and execution of clinical development strategies for oncology programs
• Serve as the primary clinical lead for interactions with PMDA, including consultation meetings and regulatory discussions
• Design and oversee clinical trials (Phases I-III), ensuring scientific rigor and regulatory compliance
• Collaborate closely with global teams to align Japan strategy with global development plans
• Provide clinical and scientific leadership across cross-functional teams (Regulatory, Medical Affairs, Biostatistics, Safety)
• Interpret clinical data and contribute to regulatory submissions and publications
• Engage with key external stakeholders, including investigators, KOLs, and academic partners

Requirements

• MD, PhD, or equivalent advanced degree in Life Sciences or Medicine
• Significant experience in clinical development within the pharmaceutical or biotech industry
• Strong expertise in Oncology clinical development
• Proven experience leading or supporting PMDA consultations and strong understanding of Japanese regulatory requirements
• Demonstrated ability to lead complex, global clinical programs
• Excellent stakeholder management and communication skills
• Fluency in Japanese and business-level English preferred

What's on Offer

• Opportunity to play a pivotal role in advancing innovative oncology therapies
• Work within a globally recognized and research-driven pharmaceutical company
• Competitive compensation and comprehensive benefits package
• Career growth opportunities in a dynamic and international environment
• Collaborative culture focused on scientific excellence and patient impact