Senior Manager Clinical Research

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Job details

Company overview

We are a leading life sciences company based in the United States, with a parent company. Our core business revolves around the research, development, importation, manufacturing, and sale of pharmaceuticals and vaccines. Every day, we strive towards our mission and goals by protecting people's health and helping them build fulfilling lives. We aim to promptly address unmet medical needs in Japan and globally. Furthermore, we actively engage in activities to promote access to medicines, including product donations and supply to those in need through various programs and partnerships.

Responsibilities

• Create Japan clinical development plan within global development strategy
• Lead clinical studies in Japan from scientific perspective
• Lead PMDA consultation related to Japan clinical development
• Develop clinical study protocols
• Support development of other study-related materials (e.g. draft Informed Consent, Case Report Form, study related SOP, etc.)
• Support study operations
• Perform medical monitoring of clinical study data
• Develop Clinical Study Reports
• Lead clinical related part of approval review
• Develop clinical sections of the Common Technical Document (CTD)
• Develop responses for clinical related inquiries
• Make presentations at scientific meetings and/or author manuscripts on clinical trials, or provide necessary support for them

Requirements

Requirements-Must:

• Clinical development experience in pharmaceutical company (5 year or more).
• Master degree or Ph.D in medical, pharmaceuticals sciences or life sciences.
• Frontier spirits and leadership to challenge unexperienced area
• Soft skills essential for a close collaboration with Japan/ex-Japan team members as well as other internal/external stakeholders
• English level equivalent to TOEIC score 800 or above

Requirements-Preferred:

• Experience in drug clinical development
• Any work experience related to biologics, and/or tissue/ cellular products

Salary

12 - 18 million yen

Location

Tokyo