Job number: JN Posted:
臨床開発リード|Clinical Development Lead
臨床開発戦略の立案と実行をリード
million yen Tokyo Pharmaceutical Clinical Development
Job details
Company overview We are a company engaged in the manufacturing, sales, import, and export of pharmaceuticals and quasi-drugs. Guided by our philosophy of "enhancing people's health and contributing to a richer society," we focus on the introduction and development of innovative new drugs, particularly anti-allergy medications. As medical technology advances with developments such as genomic drug discovery and personalized medicine, we are committed to going beyond the fundamental role of the pharmaceutical industry to support a comfortable life for people, especially in an aging society. Our business includes the import, export, manufacturing, and sales of pharmaceuticals and quasi-drugs, chemicals (such as methylamine and plasticizers), and films (such as label films and sterilization paper). We continually strive to provide truly useful pharmaceuticals to many people, always challenging and progressing forward.
Responsibilities
ベルギーに本社を置く、神経学・免疫学に特化したグローバルバイオファーマにて
【クリニカル・ディベロップメント・リード】
を募集しています。
日本法人は37年前に設立され、抗てんかん薬、関節リウマチ治療薬および乾癬治療薬を中心に医薬品事業を展開しています。
従来の治療で十分な改善が得られなかった患者さんに、新たな治療の選択肢を提供することを目指しています。
また、同社は単に業務をこなすのではなく、
価値を創造すること
を大切にしています。
挑戦を恐れず、協力し合い、革新を追求しながら、患者さんのために成果を出すことを目指しています。
誰もが尊重され、受け入れられ、最善を尽くせる平等な機会があり、思いやりと支援に満ちた文化が根付いています。
同社で働くことで、自分自身の成長を実感し、自由にキャリアを築き、
可能性を最大限
に引き出すことができます。
◤患者さんのためにあなたの力を発揮していただけませんか?◢
―――――ポジションについて
―――――
東京に拠点を置く臨床開発チームの一員として、担当製品の日本における臨床開発戦略の立案と実行をリードしていただきます。
社内外のステークホルダーと連携しながら、規制当局対応、申請書類作成、外部専門家とのネットワーク構築などを通じて、製品の成功に貢献する役割です。
■業務内容:
- 日本における臨床開発計画の立案と実行
- 規制当局との対応および申請書類の作成支援
- 外部専門家とのネットワーク構築と関係維持
- 臨床試験の設計、実施、評価、報告の監督
- 社内外ステークホルダーへの戦略説明と調整
- 薬事申請、承認、上市に向けた臨床面での貢献
■チーム
臨床開発、メディカルアフェアーズ、薬事、ファーマコビジランス、マーケティングなどの社内関係者と密に連携しながら、日本の臨床開発戦略を推進するチームで働くことになります。グローバルアセットチームや関連部門とも協働し、日本の視点を反映した開発計画を策定・実行します。
━━━━━━━━━━━━━━━#spotlightjob4
Requirements
■必須
- ライフサイエンスまたはヘルスケア分野の学士号(修士号、Ph.D.、M.D.、PharmD尚可)
- 5年以上の製薬業界での臨床開発経験
- 複数の臨床試験の同時進行管理経験
- 規制当局との対応経験および申請書類作成経験
- 戦略的思考力と問題解決能力
- マトリックス環境でのチームリーダーシップ経験
Salary million yen
Location Tokyo
BRS Consultant
Martin Tsvetkov
Industrial & Life Science
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