【AstraZeneca】【R&D】Japan Clinical Operation Program Development Lead, Development Operations, BioPharma Clinical Operation

■ 職務内容 / Job Description

Lead, Japan Clinical Operation Program (JPD, Lead) is accountable/responsible for leading the project planning for clinical operation in Japan R&D. The span of activities is broad covering clinical activities in both early and late drug development, registration/submission and post registration product maintenance phases and will include local and global working. 
The JPD, Lead is responsible for planning, oversight on related studies and mediator among Japan study team, project team and Global project/clinical team.
The JPD, Lead is one of the key members of Japan project team to represent Clinical Operation arena and to contribute JPT deliverables.   

■Key Responsibilities

1.    Project Level
・Contribute to planning and execution of Japan clinical operational part in Japan development plan with high quality insights from clinical operation arenas until ID approval, and responsible for leading a cross functional team of clinical experts in the planning and delivery of a defined clinical studies to quality, budget, time, managing resource and risk 
・Lead strategies for the site selection/patient recruitment in feasibility assessment through external key stakeholders involvement to optimize the project deliverables  
・Responsible for project management including the development, baselining and maintenance of realistic, up to date and appropriate quality, project and study plans in agreed study planning systems
・PMDA interaction; Contribute to operational strategic interaction with PMDA
・JNDA; Responsible for health authority GCP inspection management
・Key Investigators Management/Engagement ; Act as a key point of contact for clinical operations related relationship with Key investigators and National Lead Investigators
・PUBLICATION; Contribute to author selection by providing required information and act a key point of contact for author/KEE 
2.    Study Level
・Lead program operational feasibility assessment including project management of the scope, schedule and budget
・Provide operational input into study feasibility, study specifications and vendor/partner contracts 
・Handover study specification including the strategic context and the PMDA’s feedback of the clinical study discussed at Japan project team to study team
・Lead a large/complex work situation or oversight a clinical study and the process to identify and solve operational issues and drive delivery to plan through internal stakeholders or external partners engagements
・Act as a point of contact with external partners for externally managed/outsourced studies as needed 
・Oversight of the study delivery through regular communications with Global counterpart and, relevant persons in Japan study/site management functions to anticipate study requirements and mitigate risks
3.    Collaboration with Marketing Company
For study support, act as a point of contact to MSL in Medical Affairs to collaborate on e.g., Programme feasibility/KEE Engagement, developing site candidates list, information exchange on sites
4.    Others
Task outside projects; May be assigned responsibility for leadership and program/project management of non-drug project work, as the representative of Japan for the global initiatives, developing new processes in Japan R&D or the industry activities

■ 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.
・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

【Education】

＜必須 / Mandatory＞

・Bachelor’s Degree in Science or related discipline.

【能力 / Skill-set】

＜必須 / Mandatory＞

・Consistently exhibits; 

-Drives Accountability - focuses on delivery/results; meets or exceeds expectations

-Works Collaboratively - effective in leading and being a member of teams, both locally and internationally
・Creative and Innovative: Seeks to improve continuously where it counts, based on good awareness of external competitive practice, and creativity and initiative.
・Ethics - maintains high standards, including a commitment to AstraZeneca values, policies, and employment principles
・Cultural Awareness: Is aware of and sensitive to cultural differences and their impact on communication, expectations and performance.
・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

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.