【R&D】Clinical Operations Director, オンコロジークリニカルオペレーション3（Early/Hematology/GU/GI/H&N/Bladder）部
■ 職務内容 / Job Description
Japan Development Operations (J-DO) Clinical Operations Director (COD) is accountable/ responsible for:
- Planning and execution of Japan clinical operational strategy (e.g., operation part in Japan development plan) of the products within the therapeutic Area (TA) and Deasease Area (DA) portfolio.
- Leading a team of Japan Associate Directors Clinical Development (J-ADCD) , Japan Study Leader (J-SL) and the Site Management & Monitoroing (SMM) in the delivery and reporting of the clinical projects/studies within a programme to time, quality and cost.
- Managing and developing members of J-DO Clinical Operations department to achieve high level of performance and productivity with the potential that can drive studies in Japan/the global..
COD acts as a representative of Clinical Operations department against internal stakeholders (i.e. global members, R&D Japan, Medical and Sales in Japan as needed) and external customers.
COD provides TA and Disease Area (DA) Japan clinical operational expertise & input into relevant project teams, cluster teams and/or clinical sub teams to provide Japan insight and development expertise when those teams create DA and TA strategy etc.
COD secures J-ADCD to deliver right quality of deliverables, to contribute to the progress of relevant projects and to secure optimal clinical development plan to the relevant products in a timely manner.
COD secures J-SL to deliver right quality of deliverables, to contribute to the progress of relevant studies with optimal cost in collaboration with J-ADCD
COD secures SMM to deliver right quality of deliverables, to contribute to the progress of relevant studies with optimal cost/resources in terms of site management & monitoring perspectives in collaboration with SMMAD.
- Co-create/oversee creation of Japan clinical operational strategy (e.g., operation part in Japan development plan) of the products within the TA portfolio to make sure they are consistent with the business objectives, including identification of the operational risks, operational opportunities, and mitigations of the risks and engagement of key stakeholders successfully.
- Ensure strategic clinical operational TA and DA expertise and insight for optimum market access of the products in Japan as a core member of Japan TA team and/or sub-teams, and Global clinical project team.
- Lead right communications of the global Clinical Operational strategy and its implication to Japan so that the context of clinical operational input are properly understood by the governance bodies in global and Japan.
- Ensure deliverables from J-ADCD, J-SL and SMM following the latest and highest standards, minimizing risks, getting key stakeholders.
- Support due diligence process of business development by providing clinical operational assessment etc.
Leadership and Management
- Lead a cross functional sub team of clinical operational experts in the overall planning and delivery of a defined clinical project (or continuous improvement project), accountable for delivery to time, cost and appropriate quality expectations. This includes setting direction for the team and objectives for individuals.
- Lead to optimize opportunities internally and externally and to ensure clinical operational planning and execution through strategic influence to key stakeholders including Japan study/site management function’s leadership team, global counterparts and industry players.
- Demonstrate accountability for the quality of clinical operations deliverables, by confirming the process and communicating with J-ADCD, J-SL and SMM regularly and proactively to identify issues and potential risks that may jeopardize quality, and take necessary actions (e.g. updating processes, training of staff, performance management etc.) in timely manner.
- Contribute organizational strategy and execution, lead or give sponsorship to non-product functional initiatives.
- Well communicate with other relevant members, e.g., DOLT members and other divisions members to ensure JDO/R&D Japan scorecards and goals to be achieved
- Ensure performance management and personal development of J-ADCD, J-SL, and SMM, and incorporating short and long term development needs and executing the action plans.
- Conduct Performance and Talent Management (in line with HR plans), in order to attract, develop and retain the best personnel (talent base)
- Coach and guide J-ADCD and SMMAD to secure the right quality of deliverables with budget planning and controlled cost within the group.
- Have budget sensitivity in planning, monitoring and controlling all costs.
- FTE capacity planning and monitor and control workload of J-ADCD, J-SL and SMM in accordance with appropriate SHE and Compliance standards.
■ 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 clinical research organization including at least 3-years’ experience within R&D (e.g., as a member of Study Team).
- Proven experience of clinical development / drug development process in various phases of development and therapy areas.
- Exhibits experience in project management including project planning & delivery and resource management & significant budget responsibilities & execution responsibilities
- Proven Courageous leadership consistently challenging the status quo and promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
- Proven ability to transition between roles effectively and learn rapidly in a new environment
＜歓迎 / Nice to have＞
- Manages change with a positive approach to the challenges of change for self, team and the business. Sees change as an opportunity to improve performance and add value to the business
- 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
- Line management experiences in an R&D function
【資格 / License】
＜必須 / Mandatory＞
University degree (or equivalent)
＜歓迎 / Nice to have＞
Medical or biological science or discipline associated with clinical research
【能力 / Skill-set】
- Consistently exhibits;
- Leadership - leads thinking to create and achieve long-term vision and relates own activities to it; effectively influences to achieve objectives
- 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
- Influencing skills; ability to influence broadly within and outside the organization, through well thought out rationale and effective communication skills, able to influence key decisions.
- Conceptual thinking (Taking the longer term and global perspective into consideration and developing broad-scale objectives)
- 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 (Speaking level 6 or above, Achieve common understanding at the context level with customers)
【キャリアレベル / Career Level】
【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 authorisation and employment eligibility verification requirements.