Head of Global Development

The Company is seeking a Head of Global Development for Rare Diseases. This senior role is pivotal in leading the global development strategy, particularly in the European and American markets. The successful candidate will be part of a small, elite team and will have a high level of autonomy in promoting the development strategy through overseas approval applications and regulatory authority responses. Key responsibilities include planning and implementing overseas development strategies, collaborating with external experts, formulating policies, and managing the entire process of overseas vendor relationships, clinical trial-related applications, and project progress. The role also involves extensive internal and external stakeholder management, as well as coordinating with regulatory authorities. Applicants must have over 10 years' of experience in overseas clinical trials and regulatory approval applications within a pharmaceutical company or CRO, with a background in a PM/CL or Department Head position. A Bachelor's degree in a science-related field is required, along with fluency in Japanese and business-level English. The ideal candidate will have a strong scientific background, experience in international regulatory approval applications for new drugs or additional indications, and a proven track record of effective communication and stakeholder management. The company values long-term employment and offers a comfortable working environment, including a remote work system and a retirement age of 65.