Job summary
Job category | Professional (Consulting / Finance / Real Estate / Professional Services)/Professional Services (Health Care / Welfare / Education / Instruction) |
---|---|
Industry | Health Care/ Other Health Care |
Employment type | Uncategorized |
Position level | Other |
Number of openings | 1 |
Desired entry time | - |
Required language skill |
Japanese (Fluent) |
Foreign language competence | - |
Working hours | Others |
Welfares / Leave systems | |
Assistance in visa application | - |
Number of foreign employees | - |
Work details
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
About interview
Liaison
Japan Clinical Director(Oncology)
RGF HR Agent
1000 〜 1800 ten thousand JPY