Impress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Tailor your resume to this Japan Clinical Development, Senior Manager role.
Rezi rewrites your resume against Morunda K.K.'s job description. Free.
Tailor your resume to this Japan Clinical Development, Senior Manager role.
Rezi rewrites your resume against Morunda K.K.'s job description. Free.
Don't guess if your resume is good enough.
See how it scores against the Japan Clinical Development, Senior Manager posting at Morunda K.K. — free, in seconds.
Don't guess if your resume is good enough.
See how it scores against the Japan Clinical Development, Senior Manager posting at Morunda K.K. — free, in seconds.
About the Role
Lead Japan clinical development strategy for assigned products, translating global development plans into effective Japan-specific clinical and evidence-generation strategies. The role also leads a cross-functional Japan Product Strategy Team, working closely with Clinical, Medical, Regulatory, Value & Access, Commercial, and Development Operations teams to support successful development, registration, and commercialization in Japan.
Responsibilities
- Lead Japan Clinical Development and Evidence Generation Plans in alignment with global strategy.
- Provide Japan-specific clinical and medical insights on treatment guidelines, unmet needs, and clinical development.
- Partner with Regulatory, Safety, Value & Access, and Development Operations on clinical and regulatory activities.
- Provide clinical input into PMDA interactions, regulatory submissions, and NDA activities.
- Lead cross-functional Japan product strategy and align stakeholders around key priorities.
- Support clinical studies through investigator meetings, site activities, inspections, and other medical/scientific activities.
- Coach and support team members and promote effective cross-functional collaboration.
Requirements
- 5+ years of clinical development experience in the biopharmaceutical industry.
- Experience leading clinical development projects or cross-functional development teams.
- Experience working on global clinical development programs and adapting strategies for Japan.
- Strong understanding of Japanese clinical development, PMDA regulations, and drug development processes.
- Experience with NDA filing and/or early-phase clinical development preferred.
- Strong cross-functional leadership and strategic thinking skills.
- Medical degree, PhD, Master’s, or equivalent relevant experience.
- Fluent English and business-level Japanese.
Experience Level
- 5+ years of clinical development experience
Education Level
- Medical degree
- PhD
- Master’s
- equivalent relevant experience