【AstraZeneca】【R&D】Associate Director Study Alliance Management, Development Operations Division

■ 職務内容 / Job Description

Associate Director Study Alliance Management (ADSAM) is accountable/responsible for oversight of related full outsourcing studies to achieve milestones as scheduled with maintenance of quality and mediator among Japan CRO study team, Global CRO representative, Japan Associate Director Clinical Development (J-ADCD) and AZ Global clinical team. 

The ADSAM will contribute to optimize an alliance on full outsourcing studies from the planning to the regulatory inspections  (e.g., create/improve oversight platform, the agreement and Japan specific requirements through influencing global alliance team members, and optimize upcoming study operation planning/execution by J-ADCD). 

The ADSAM will take capability and skill development for Japan Study Manager (J-SM) and contribute to improve related activities in the Japan Development Operations (J-DO). 

■ 応募資格（経験、資格等）/ Qualification (Experience & Skill etc.)

【経験 / Experience】

＜必須 / Mandatory＞

- At least 5 years’ experience in pharmaceutical industries or multinational healthcare organization. 
- Extensive knowledge of clinical operations, project management tools and processes 
Proven experience of clinical development / drug development process in various phases of development and therapy areas including health authority GCP inspection. 
- Proven ability to learn by working in multiple phases, TAs and/or different development situations. 
- Experience from leading clinical projects and deliverables or similar expertise from other areas of drug development (such as pharmaceutical development).  

＜歓迎 / Nice to have＞

'- Working with external bodies, such as co-development companies and key opinion leaders, as a leading person. 
- Leadership of significant cross-functional change programmes/initiatives 

【資格 / License】

＜必須 / Mandatory＞

Bachelor’s Degree

＜歓迎 / Nice to have＞

Medical or biological science or discipline associated with clinical research 

【能力 / Skill-set】

＜必須 / Mandatory＞

- Extensive knowledge of clinical operations, project management tools and processes 
- Understanding of the skills and knowledge required for the successful delivery of a clinical study, e.g. ICH-GCP/J-GCP, local regulations, study management 
- Good experience of clinical development / drug development process in various phases of development and therapy areas 
- Excellent communication, relationship building, and negotiation skills 
- Proactively identifies risks and issues and possible solutions 
- Basic knowledge and experience of quality management 

【語学 / Language】

＜必須 / Mandatory＞

日本語 Japanese：ネイティブ

英語 English：英語 English： Business English (Achieve common understanding at the context level with customers)

【キャリアレベル / Career Level】

E

【勤務地 / Work Location】

Osaka or Tokyo