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
医療・介護・福祉 - 医師

1. Leads the Clinical Team, a cross functional, team of internal experts, through clinical phase I – III trials, and global product registration. Deal with relative complex projects (e.g. co-development with another company). Sets project-related objectives with team members. Requests clinical team members and clarifies resource availability with functional heads.
2. Act as a member of the J-Project Team representing Clinical Development (CLD) and member of the Launch team, representing CLD. Build consensus by complying input from multiple functions.
3. In consultation with relevant key disciplines, prepares the Clinical Development Plan (CDP). Responsible for planning and managing the clinical timelines, against the approved CDP. Provides domestic study concepts to ensure compliance with global strategy. Proactively initiates corrective action as needed.
4. Responsible for the ongoing risk-benefit assessment of a compound until approval in Japan. Analyses incoming clinical data, relevant medical and scientific information and initiates actions or decisions as appropriate.
5. In consultation with the Head of CLD and Global Clinical leader, responsible for assessments and communication of medical project and study strategy, study results and clinical project results to internal and external bodies (e.g. regulatory authorities).
6. Responsible for defining the strategic approach and managing preparation of medical sections of key Regulatory documents (J-CTD Module 2s). Consults with Global clinical leader, Clinical Science, Clinical Statistics, Regulatory, PHV. Compiles and maintains Translated Investigators’ Brochures (IB).
7. Provides medical expertise to Marketing (for marketed products and for development projects) and defines together with the Medical Affairs (MA) the publication strategy. Ensures consistency of publications with clinical data and publication strategy. Contributes to Opinion Leader development and publications strategy with implementation detail. Establishes and maintains appropriate external scientific advisory boards and assists in advocacy development. Provides medical assessment of in- and out- licensing opportunities of development projects.
8. Conducting Clinical Development tasks independently while seeking advice on exceptional or complex topics from senior clinical leaders and/or managers

■休日：完全週休二日制, 土, 日, 祝日, 夏季休暇, 年末年始

【学歴・資格】
■M.D or PhD holder is preferred with extensive professional and academic experience in relevant areas, or a person with proven equivalent background.

【経験・職務に必要な能力】
Board certification in a relevant therapeutic area is preferred but not a must. Key competencies needed by the candidate include the following:
• In-depth understanding of the drug development and commercialization process with a base of experience of 8+ years in Medical Science / Clinical Practice and drug development (From protocol writing to Medical review report).
•Someone with Oncology TA experience is mandatory for this role <Technical Skills>
• Proven leadership, motivational and interpersonal skills
• Must provide clear vision, direction, and purpose in the different cultures present within R&D Japan (RD-J) as well as the global Medical Organization (e.g. for function goals, RD-J vision)
• Incumbent must embrace change and be able to work in a changing environment
• Strong communication and analyzing skills to ensure that project plans and status are transparent, and that risks, issues, and results are clear to all involved parties. A matrix structure requires additional skills in gathering decision information, negotiation and communicating decisions and action.
• Executes his/her responsibilities with knowledge, accuracy, persistence, resilience and creativity seeking to work both independently and collaboratively
• Guide junior members adequately.
• Native level of writing skills in Japanese (e.g. for J-CTDs/PMDA’s inquiries)

【スキル・語学レベル】
Good communication skills in English (i.e. TOIEC 730 + professional working proficiency)

■職種未経験者：不可