外資系大手製薬メーカー【R&D】 Project Physician, 研究開発本部 バイオファーマ領域統括部 メディカルサイエンス部
- 会社区別外資系製薬メーカー
- 職種メディカルドクター
- 勤務地大阪、東京
- 年収1200~1700万円(スキル・経験により決定)
資格・要件
【経験 / Experience】
必須 Mandatory
4-5+ years' experience of 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 KEEengagement
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
語学 Languages
必須 Mandatory
英語 English: Business English
日本語: Native level
その他
歓迎 Nice to have
A specialist of metabolic disease is preferred
【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
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 the company ensures patients access to valuable medicines and 2) Leadership and appropriate behaviors.