お仕事情報

お仕事情報

Senior Medical Advisor(Oncology):SS-3812MY

  • 外資系企業
  • 女性が活躍
  • 管理職・マネジャー
  • 英語を活かす

世界最大の独立バイオテクノロジー企業と、内資系研究開発型グローバル製薬企業との合弁会社

求人コード SS-3812MY
募集職種 Senior Medical Advisor(Oncology)
職務内容 Responsible for:
・Provide in depth local medical/clinical and scientific (as applicable) insights to local and global product teams
・Product(s) lifecycle management
・Leading and developing the Local Medical strategy and Medical activities for the product candidate(s) in accordance to internal and external regulations and in close collaboration with all other functions as needed
・TA and/or product specific Medical training
・Management of internal and external relationships within area of responsibility
・Ensuring consistency of Medical content and scientific messages across various tools and materials
・Providing in depth local medical/clinical insights

Key Activities:
・Participates in the development of Japan strategies and tactics under supervision of our Medical Director and in close collaboration with our product teams (PT) and the PSTs and all relevant functions with us
・Supports local study concept development and protocol preparation (as well as global studies with Japan participation) in close collaboration with our GDT and DCD, based on agreed upon development strategy, all in line with our processes and policies
・Visits selected KOL’s and study groups for strategic discussions and protocol development
・Participates in/plans and conducts Local Advisory Board Meetings, Investigator Meetings and/or Expert Panels
・Contributes to the formulation of regulatory submission strategy
・Provides Medical expertise for pipeline products
・Provides Medical expertise for Health Economy and reimbursement requests
・Member of our PT and Joint Product Team
・Collaborates closely with our PT, Development Operations (DO) and all other functions as needed to ensure preparation, implementation and completion of our sponsored studies)
・Provides input into site selection for our sponsored studies
・Review IB, SCD/protocol, study report
・Contribute to preparation of CTD as appropriate
・Reviews Japan Investigator-Sponsored Study (ISS) proposals to ensure scientific validity, prior to appropriate governance-based review
・Collaborates with our PTs, JPTs and PSTs as well as our Marketing and Scientific
Affairs teams in the development and execution of the Japan product(s) lifecycle
management plan
・Develops and executes better recruitment strategies in conjunction with Local Development Operations (DO) team
・For early development projects, collect relevant information on local medical/clinical environment, provide it to PT with strategic options and recommendations.
応募要件 <Qualifications>
Medical education (MD) or deep scientific expertise in relevant therapeutic area

<Skill, Experience and Knowledge>
・Minimum of 2 years in pharmaceutical industry, or proven industry collaboration in academia
・Experience in Medical Affairs and Clinical Development
・Experience with clinical study management and conduct
・Knowledge of commercialization and business practices
・Deep understanding of pharmaceutical product development, product lifecycle and commercialization process with advanced understanding of other functions; including but not limited to Clinical Operations, Commercial, Regulatory, and Medical Affairs, Value Access and Policy
・Existing therapeutic area knowledge and demonstrated ability to rapidly develop deep understanding of new therapeutic areas
・Strong customer orientation; science based and marketing minded
・Existing network of OL contacts in therapeutic area
・Finance and budgeting experience
・Operational excellence: self management skills, planning, prioritization, objective setting, meeting management, plan execution
・Interpersonal skills: ability to engage with key stakeholders at a professional and clinical level
勤務地 東京
年収 1500万円~2000万円以上
最終学歴 修士卒
推奨される資格要件 医師(MD)、PhD、理系
その他

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