senior manager, senior japan clinical lead.

Position ResponsibilitiesAccountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with the support of the CTPs within the asset and/or indicationAccountable for the design, execution, and analyses of each studyAccountable for clinical content for CSRs and regulatory documents (e.g., briefing books submission documents and regulatory responses)Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conductRepresents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development functionProvides clinical leadership and disease area expertise into integrated disease area strategiesCollaborate and serve as primary liaison between external partners for scientific adviceServes as Primary Clinical Representative in Regulatory interactionsSets executional priorities and partners with CTP and operation team to support executional delivery of studiesAccountable for top line data with support of CTP and StatisticiansMaintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team membersEvaluate innovative trial designs (collaboration with Japan CTP)Ensure global clinical study protocol is applicable to local medical practice (manage local protocol amendment, if needed)Proactively identifies potential study level risks and drives the execution of mitigation strategiesServe as CS in Japan local studies　　・Responsible for implementation, planning, and execution of assigned clinical trial activities　　・Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision　　・Co-Leads study team meetings in partnership with Global Trial Manager; and collaborate with cross functional study team members　　・Plan and lead the implementation all study startup/conduct/close-out activities as applicable (collaboration with GTM)　　・Protocol and ICF development process; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality(collaboration with Scientific Writing)　　・Site-facing activities such as training and serving as primary contact for clinical questions　　・Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review (collaboration with DM)　　・Clinical data trend identification; provide trends and escalate questions to Japan CTP　　・Develop clinical narrative plan; review clinical narratives　　・Provision of information required by Global Trial Manager for development of trial budget, CRO scope of work, etc.　　・Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC)activitiesDemonstrate leadership as an active member of cross functional teams, task forces, or local and global initiativesEffectively influence team and collaborate with senior stakeholders, address complex problems and challenges with positive outlook, able to deliver results with high level professionalismCoach the CL in the Clinical Lead work for development of products in Japan from study planning to JNDA filing and thereafter

求められる経験
Degree Requirements
MD/PhD/PharmD/MS preferred

Experience Requirements
A minimum of 5 years of clinical development / industry experience preferred
Expertise in the design, analysis, publication and execution of multiple clinical trials (e.g. significant experience as a senior clinical leader).
Adequate knowledge of pharmaceutical development process.
Strong experience in clinical science, clinical research, or equivalent
Experience in a matrix team composed of multiple functional organizations.

保険
健康保険　厚生年金保険　雇用保険

休日休暇
土曜日　日曜日　祝日

給与
年収1,200 ～ 1,600万円

賞与
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