臨床開発 [ID: 0020]

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

  • 会社区別外資製薬メーカー
  • 職種Project Physician, R&D Late Development Oncology
  • 勤務地東京、大阪
  • 年収~1500万円

資格・要件

Clinical practice as physician

<歓迎 / Nice to have>
l Clinical practice in Japan
l Strong physician network related to the therapeutic area
l Experience and knowledge in drug development including study execution, regulatory
interaction, and product launch
l Experience in KEE engagement
l Work experience outside Japan
l 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 English
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 ○○ 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 ○○ ensures patients access to valuable medicines and 2) Leadership and appropriate behaviors.

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