Location: Japan - Tokyo
Job Type: Permanent
Salary: 10000000 - 18000000 JPY
Job Function: Clinical Development
Reference: JO-170421-125882
Industry: Life Sciences & Healthcare
Sub-Industry: Pharmaceuticals

Company Overview

大手外資製薬メーカー/オンコロジー領域へ注力/福利厚生充実

Job Description

- Oncology領域の早期、後期開発のプロジェクト・リード
- 戦略的開発計画の立案、プロトコール考案、総括報告書作成の業務マネジメント
- 臨床試験実施のための社内外における折衝(社内関連部署、CRO、KOLとの折衝)及び進捗管理
- 海外グローバルチーム・カウンターパートとの協業
- 規制当局への対応

The Clinical Director will:
- Lead the development of Oncology projects (early and late phase)
- Development of strategic plans, protocol plans and managing Clinical Study Reports (CSRs).
- Communication with internal/external stakeholders (w/ functions within the company, CROs, and external KOLs) and managing clinical trials.
- Collaboration with global teams/counterparts
- Communication with PMDA/MHLW, functioning as a clinical leader and working with regulatory colleagues

Requirements

- 製薬会社でのOncology領域プロジェクトリーダーとしての臨床開発実務および承認申請業務の経験者
- Oncology領域における疾患知識
- KOLマネジメントおよび社内外メンバーとのコミュニケーション能力
- ビジネスレベルの英語力(海外(主に米国)と交渉可能なレベル)
- チャレンジ精神旺盛な方
- Working experience in the pharmaceutical industry as the lead for clinical development and regulatory submissions in the Oncology area
- Knowledge of Oncology (disease, clinical development & strategy)
- Excellent communication skills needed for KOL management and internal/external stakeholders.
- Business level English skills (capability to discuss with global member in English)
- Competency: willing to face challenges head on