The Japan Program Clinical Head is responsible for clinical program activities for approval and post approval commitment for Re-examination in Japan across multiple indications and compounds
Job Summary
The Japan Program Clinical Head is responsible for clinical program activities for approval and post approval commitment for Re-examination in Japan across multiple indications and compounds.
This role involves close collaboration with global and Japan project teams to design, implement, and execute clinical development programs supporting regulatory approval and market access.
Novartis offers an inspiring environment that empowers employees to explore digital and data innovations while tackling the world’s toughest medical challenges.
Matching Summary
The Japan Program Clinical Head is responsible for clinical program activities for approval and post approval commitment for Re-examination in Japan across multiple indications and compounds.
Skills & Requirements
Must-have
Clinical program leadership in Japan
Regulatory submission and compliance
Clinical trial design and execution
Cross-functional team collaboration
Medical and scientific expertise
Risk-benefit assessment
Health authority interaction
Nice-to-have
Coaching and mentoring skills
Disease area strategy contribution
Negotiation and diplomatic skills
Fluent English communication
Clinical development culture fostering
Key Requirements
Advanced degree in life sciences or clinically relevant field
Minimum 5 years clinical research or drug development experience
Thorough knowledge of GCP and GPSP
Experience with regulatory submissions and health authorities