Naoko MatsushimaSenior Director,
Program Management

Naoko Matsushima has 27 years of experience in the pharmaceutical and CRO industries.
She joined JCRO in 2019 and serves as Senior Director of Clinical Program Management, overseeing the strategic and operational management of clinical development programs in Japan.
She also manages interactions with regulatory agencies and has successfully contributed to Japan Orphan Drug Designation filings for rare disease programs.

A key part of Ms. Matsushima’s work at JCRO has been supporting the company’s approach to incorporating Japan into global development programs for rare disease therapies being developed overseas, particularly from Phase III onward.
This strategy is designed to help emerging biotech companies build an efficient pathway toward Japanese development and registration as part of their broader global plan. At JCRO, Ms. Matsushima’s project management approach focuses on aligning the right internal and external talent and resources to achieve each program’s goals, building those elements into an effective development plan, and delivering the regulatory and clinical objectives agreed with sponsors on timeline and within budget.
She also ensures that regulatory and clinical activities in Japan are closely coordinated with sponsors’ global development plans so that Japan can move forward in step with the broader program.
Prior to joining JCRO, Ms. Matsushima spent more than 20 years at Quintiles/IQVIA Japan, following six years at global consulting firm, Andersen (Accenture) Consulting.
She began her CRO career in business development when CRO were still emerging in Japan.

As the CRO industry expanded in Japan, Ms. Matsushima built broad leadership experience across business management and operations.
In her final four years at Quintiles, she led the Japan drug safety group, expanding capabilities from clinical trial safety to post-marketing pharmacovigilance.
She also supported the launch of Japanese pharmacovigilance services in Dalian, China.

Ms. Matsushima’s broad experience makes her a valuable partner for global biotech companies seeking to accelerate development and create a clear path into Japan.