臨床開発 [ID: 0046]

外資系製薬メーカー Project Physician, R&D Late Development Oncology

  • 会社区別外資系製薬メーカー
  • 職種Project Physician, R&D Late Development Oncology
  • 勤務地大阪市北区、東京都港区
  • 年収1100~1700万円

資格・要件

【経験 / Experience】<必須 / Mandatory>
Clinical practice as physician
<歓迎 / Nice to have>
・Experience in Oncology field
・Clinical practice in Japan
・Strong physician network related to the therapeutic area
・Experience and knowledge in drug development including study execution, regulatory
interaction, and product launch
・Experience in KEE engagement
・Work experience outside Japan
・Publication record to peer-review journals in English
【資格 / License】<必須 / Mandatory>
Medical Doctor degree required
<歓迎 / Nice to have>
Doctor of Philosophy, Board certification related to the therapeutic area
【能力 / Skill-set】<必須 / Mandatory>
・Logical thinking
・Effective Communication
・Medical writing skill
・Presentation skill
・Collaborative skills as a team member, both locally and internationally
・Leadership capability
・Rapid adaptability to a new environment
・Project management skill                                             
・Negotiation skills, assertiveness
【語学 / Language】<必須 / Mandatory>
英語 English: Business日本語: Native level

職務内容

Project Physician (PP) is a medical expert who is accountable/responsible for generating clinical development strategy, designing clinical development options, and delivering successful clinical development programs for 〇〇 assets in Japan.
His/Her accountability/responsibility is mainly at project-level, such as generation of Japan clinical development strategy in collaboration with Clinical Scientist (CS) by providing expert knowledge as a physician-scientist. PP also shares the ownership with CS for any discussions of clinical part of JNDA strategy. PP is also involved in study-level activities as needed.
Other important responsibilities include: PMDA/MHLW interaction: 1) Co-development of documents for regulatory interactions such as BD for regulatory consultation, and 2) Query responses as a medical expert through collaboration with CS. KEE management: PP is responsible/accountable for KEE engagement from R&D perspectives including but not limited to group advisory board mtg and 1:1 consultation as local internal medical expert
The measure of success includes: 1) The quality and quantity of medical/clinical deliverables mentioned above for 〇〇 ensures patients access to valuable medicines and 2) Leadership and appropriate behaviors.

【その他情報】
契約期間:期間の定めなし
試用期間:6か月
就業時間:9:00~17:15
休憩時間:60分
フレキシブルタイム:あり
時間外労働:あり
休日休暇:
完全週休2日制(休日は土日祝日)
年間有給休暇 初年度12日
年間休日日数121日

■公休日:完全週休2日制(土、日)・祝日・年末年始6日
■休暇:年次有休休暇・慶弔・赴任・リフレッシュ
受動喫煙対策:あり 就業場所 全面禁煙
加入保険:雇用・労災・健康・厚生年金保険
在宅勤務制度:有

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