メディシン第１部長/部長職/医薬開発本部クリニカルデベロップメント・メディカルアフェアーズ心・腎・代謝領域メディシン第１部
Basic purpose of the job
To contribute to global clinical drug development by executing CDMA activities in Japan according to TA strategy between start of preclinical development and late stages of commercialisation
Accountabilities
Contribution to Clinical Development Plan (CDP) between start of preclinical development and late stages of commercialization aligned with global development and medico-marketing strategy
Related performance indicators
CDP contributions confirmed at HPSC
Ensure Japanese submission and registration are appropriately handled and obtained
Related performance indicators
Timely submission and registration
Ensure to prepare and execute IBPs (e.g. PMO plan, Data building, medico-marketing, publication, EEE )
Related performance indicators
To conduct MR training in order to improve knowledge level of MR, based on request from training department
Responsible for TA budget control, Management of staff in TA, contribute to Japanese drug development by developing and providing staff for NBI functions (eg. CPL, TA) and for global functions (eg. TMM, TMMA)
Related performance indicators
Ensure proper staffing and adhere to effective cost management according to budget
Ensure all the projects are correctly managed in timeline and quality
Related performance indicators
Achieve project milestone contributions according to the plan agreed with Core Team
Ensure re-examination by reviewing documents and process, ensure benefit/risk evaluations of products in TA
Related performance indicators
Ensure successful re-examination and availability of adequate benefit / risk evaluations at all documents for all products and projects
Support subordinates to develop his/her expertise, Competencies, international communication skills etc.
Related performance indicators
Provide subordinates with development opportunities
Support subordinates to create/develop his/her develop career plans
Secure the successor of the position
Regulatory and / or Organisational Requirements
Ensure ethics and compliance. Provide timely updates of NBI pipeline information across NBI organisation. Ethical conduct of HCP interactions in TA. Ensure adherence to purchasing guideline in TA initiated contracts. Talent management. Serve as contact for local Communication Department
Output documents
Quarterly TA update report, contributions to CDP/IEP, updated cost tracking sheets, updated OBI reports from CTMS, Talent Management, local integrated brand plans
Job Complexity
Work in a cross-functional team, global TA, respective Business Unit
Interfaces
Integrated brand team, rapid response team, MST, MAST, TMMA, TMM, Team Member Global Epidemiology, local R&D team members, JPT
Job Expertise
Full understandings of regulatory and compliance requirement in clinical development and medical affairs
Minimum Education/Degree Requirements
Bachelor of Science
Required Capabilities (Skills, Experience, Competencies)
BI Japan in-house coaching skill （BI Japan 社内コーチングスキル）
TA experience in clinical or research setting with own publications, 5+ year’s industry experience in Japan in Clinical Drug Development. Leadership. English speaking.
Required English speaking CEFR level : C1
Recruiter：Tomatsu