- 常勤
- 東京都
【東京都千代田区・大阪府大阪市】外資系大手製薬メーカー臨床開発
Clinical Leader 週5日勤務 フレックスタイム制
- 300422289
- 2026年02月16日更新
- 当直なし
- オンコールなし
| 勤務地 | 東京都千代田区、大阪府大阪市 |
|---|---|
| 給与（年収） | 1000万円 応相談 |
| 募集科目 | 一般内科、製薬会社 |
| 交通アクセス | *** |
| 医療機関区分 | その他会社 |
| 病床数 | ・・・ |
| 屋内の受動喫煙対策 | 敷地内禁煙 |
求人情報
勤務内容・条件
| 募集科目 | 一般内科、製薬会社 |
|---|---|
| 勤務内容 | その他 対象専門科目：内科、※抗がん剤治療経験 仕事内容： Leads the Clinical Team, a cross functional, team of internal experts, through clinical phase I – III trials, and global product registration. Deal with relative complex projects (e.g. co-development with another company). Sets project-related objectives with team members. Requests clinical team members and clarifies resource availability with functional heads Act as a member of the J-Project Team representing Clinical Development (CLD) and member of the Launch team, representing CLD. Build consensus by complying input from multiple functions In consultation with relevant key disciplines, prepares the Clinical Development Plan (CDP). Responsible for planning and managing the clinical timelines, against the approved CDP. Provides domestic study concepts to ensure compliance with global strategy. Proactively initiates corrective action as needed Responsible for the ongoing risk-benefit assessment of a compound until approval in Japan. Analyses incoming clinical data, relevant medical and scientific information and initiates actions or decisions as appropriate In consultation with the Head of CLD and Global Clinical leader, responsible for assessments and communication of medical project and study strategy, study results and clinical project results to internal and external bodies (e.g. regulatory authorities) Responsible for defining the strategic approach and managing preparation of medical sections of key Regulatory documents (J-CTD Module 2s). Consults with Global clinical leader, Clinical Science, Clinical Statistics, Regulatory, PHV. Compiles and maintains Translated Investigators’ Brochures (IB) Provides medical expertise to Marketing (for marketed products and for development projects) and defines together with the Medical Affairs (MA) the publication strategy. Ensures consistency of publications with clinical data and publication strategy. Contributes to Opinion Leader development and publications strategy with implementation detail. Establishes and maintains appropriate external scientific advisory boards and assists in advocacy development. Provides medical assessment of in- and out- licensing opportunities of development projects Conducting Clinical Development tasks independently while seeking advice on exceptional or complex topics from senior clinical leaders and/or managers |
| 週勤務日数 | 5.0日 |
| 勤務時間 | (月～金) 09時00分 ～ 17時30分 9：00-17：30 （休憩時間60分） フレックスタイム制 |
| 当直 | なし |
待遇・手当
| 給与（年俸） | 1000万円 応相談 |
|---|---|
| 赴任手当 | - |
| 住宅手当 | - |
| 宿舎の提供 | - |
| 自動車通勤 | - |
福利厚生
| 休日 | 日曜日、祝日、土曜日 |
|---|---|
| 休暇 | 季節休暇、年末年始、初年度有給休暇 |
| 研究日 | なし |
| 社会保険 | 健康保険、雇用保険、労災保険、厚生年金 |
| 学会出席 | - |
その他
| 試用期間 | あり（3カ月）同条件 |
|---|---|
| 備考 | ・勤務地：東京都千代田区、大阪府大阪市 ・年収1000万円～（目安）※経験・スキルによります。 ・時間外労働：あり ・加入保険 社会保険：健康保険、厚生年金保険 労働保険：雇用保険、労働者災害補償保険 【必須条件】 ・医師免許（抗がん剤治療経験） ・医薬品開発（プロトコル作成から医療レビュー報告書まで）の実務経験を有すること ・ビジネスレベルの英語力 【歓迎スキル】 ・PhD保有 |
