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| 部署・役職名 | Global Clinical Strategy Lead |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
【職務概要】 Global Clinical Strategy Lead （GCSL） is responsible for the Japan clinical development of products, their maintenance and life cycle management for products in scope include relevant company originator key brands as well as portfolio－associated products and other branded originator products. This includes the entire clinical development process starting with preparation of development plans up to support of drug approval, launch, and life cycle management, is also responsible for review and evaluation of external and internal product opportunities from a clinical strategy and development perspective in collaboration with cross functional departments. The person will provide medical and strategic leadership in identification, evaluation, and clinical due diligence of differentiated and novel products in the assigned therapeutic area. GCSSL will also be responsible for providing clinical strategic program leadership for the clinical development of assigned products. This position will lead a highly matrixed organization to establish, develop and execute robust clinical development programs in assigned therapeutic areas across various verticals. This role works collaboratively with Global Business Development （GBD）, Portfolio, Global Commercial Development （GCD）, Global and Regional Medical Affairs, Global Clinical Operation Leads, Biometrics, Regulatory Affairs, Development Program Leaders, PK－DM Scientists, Vertical R＆D Leaders, and other key internal stakeholders to achieve the goals of the organization. Ensures compliance with the Standard Operating Procedures （SOPs）, current Good Clinical Practices （GCP）, and regulatory requirements. All tasks are conducted according to GxP including GCP, legal requirements and applicable company working standards （SOPs）. |
| 労働条件 | 同社では全面禁煙となっており、採用も非喫煙者の方が対象となっております。 |
| 応募資格 |
【必須（MUST）】 ・Experience in early and late stage clinical drug development in regulated markets in a responsible role （like clinical development lead）.・Knowledge and understanding of Good Clinical Practice and other associated regulations, guidelines, and industry standards for clinical trials is required. 【歓迎（WANT）】 • Experience as a project leader for new drug development in a pharmaceutical company is preferred.• Experience in filing NDA and obtaining approval for new drugs in a pharmaceutical company is preferred. |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2025/05/13 |
| 求人番号 | 4643523 |
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- 会社規模501-5000人
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- LHH完全独占案件/ フランス系体外診断薬・診断機器メーカーにて営業を3名募集中です。 事前にオンライン説明会も予定しています。ご興味のある方はぜひお問い合わせください。
- (2025/01/07)
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です