メディカル・バイオ - 臨床開発リーダー・臨床開発プロジェクトマネージャー

■ 職務内容 / Job Description
・The Project Leader is a cross-functional project leader of relevant Project Team to build and execute project strategy (ies) of a development product(s), including NME project(s) and/or LCM project(s) which require clinical trial(s) in Japan

・The Project Leader provides the leadership to the project team(s) to build high performing team(s) for maximizing the value of product(s) in Japan

・The Project Leader is accountable for the responsible project strategy (ies), and is a single point of contact from the global team(s), and the relevant function in marketing company such as Commercial/Medical functions as well as external co-development partners where applicable

■休日：完全週休二日制, 年末年始

■ 応募資格（経験、資格等）/ Qualification (Experience & Skill etc.)
【経験 / Experience】
＜必須 / Mandatory＞
・Extensive leadership and project management experience in multi-disciplinary drug development environment
・Experience and knowledge in drug development including study execution, regulatory interaction, and product launch
・Experience of radio pharmaceuticals (e.g. radiocondjugates) development


＜歓迎 / Nice to have＞
・Experience on negotiation with PMDA/MHLW, and getting JNDA/sJNDA approval and supporting launch activities
・Negotiation with external experts/stakeholders
・Drug development experience in outside of Japan

【資格 / License】
＜必須 / Mandatory＞
Bachelor’s of Science in an appropriate discipline

＜歓迎 / Nice to have＞
Doctor of Philosophy
【能力 / Skill-set】
＜必須 / Mandatory＞
・Engaging and inclusive team leadership skill – to motivate, inspire project team members, and influence to stakeholders around key decisions through well thought out rationale and effective communication
・Being responsible for making decision(s) and communicating decision(s) clearly to Project team members and stakeholder(s)
・Actively seeking to collaborate in a matrix organisation and holding people accountable
・Being able to have a broad outlook and to see our conduct and ourselves from internal partners and external customers
・Assertive communication skill ・Coaching skill – to develop project team members
・Thorough knowledge and experience of drug development process
・Fluent in spoken and written English for business

【語学 / Language】
＜必須 / Mandatory＞
英語 English： Business English
日本語: Native level

■職種未経験者：不可