• Job number: JN -072024-25955 Posted: 2024-09-11

  【横浜】創薬におけるバイオロジクスDMPK研究者

  創薬の非臨床薬物動態研究での実務経験が活かせます。

  6 - 11 million yen Kanagawa Pharmaceutical Research & Development

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  Company overview

  We are engaged in the research, development, manufacturing, and sale of pharmaceuticals. We strive to maintain independent management, research, development, production, and sales functions, along with our unique international expansion efforts and the strengthening of our research and development capabilities. Focusing on strategic areas such as "cancer," we are accelerating the creation of promising new drugs, including antibody drugs. We also actively pursue global expansion, aiming to provide high-quality pharmaceuticals and services to patients worldwide.

  Responsibilities

  様々な新規分子形を有するバイオロジクスの薬物動態特性をメカニズムに基づき定量的に明らかにし、分子最適化の方向性を提示すると共にヒトPKPD予測を通してプロジェクトの成功確率を提示する。
  技術課題解決のための新技術確立、ならびにアカデミアや海外関連会社との共同研究を通じた外部からの技術導入の推進役を担う。
  

  

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• Job number: JN -072024-37929 Posted: 2024-09-11

  Pricing & External Affairs Senior Manager

  Pricing Senior Manager position at global mega pharma

  12 - 18 million yen Tokyo Pharmaceutical Market Access / Pricing / HEOR

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  Company overview

  This company is the world\'s leading pharmaceutical company.

  Responsibilities

  Responsibilities
  Develop strategic NHI pricing strategies and gain endorsement of NHI pricing strategies and proposals of NHI prices with Country President and TA Leads through the Pricing Committee
  Develop robust pricing dossiers and strategically manage price negotiations
  Build strong alignment & partnership among Japan Pricing Core members (New Asset & Access Strategy team, New Asset Analysis team, DJ, Medical, Launch Excellence Team, Policy and Public Affairs, and the global PHI) to ensure optimal price setting
  Develop Pricing-related OP assumptions
  Refresh pricing assumptions and estimated prices for pipeline products and BD assets to reflect the latest competitive environment
  Minimize the downward price adjustment by price revision/repricing through cross-functional collaboration
  Maintain good relationship with “Policy Planning Division for Pharmaceutical Industry Promotion and Medical Information Management, MHLW” (former EAD) and act as a mediator between the company and MHLW to flawlessly manage all product-related issues, as well as NHI pricing negotiation
  Actively participate in trade association activities (FPMAJ, PhRMA, FIRM, etc.) to establish a pro-innovative pricing framework
  Contribute to building a high performing team by actively engaging in coaching junior colleagues and nurturing a positive environment where people feel energized and eager to speak up
  

  

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• Job number: JN -072024-27839 Posted: 2024-09-11

  【東京／8月以降入社】MSL（血液領域）～豊富なキャリアパス／研修・教育環境充実～

  血液領域における経験ある方歓迎

  6.5 - 9.5 million yen Tokyo Pharmaceutical Medical Affairs

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  Company overview

  We are a global healthcare company and the largest provider of biopharmaceutical development and commercial outsourcing services. In today\'s rapidly changing environment surrounding the healthcare industry, we are making a significant contribution to the development of the industry through its four business segments: Clinical Development, Sales & Marketing, Investment & Alliances, and Consulting. The company, which has supported the development and commercialization of the top-selling drugs worldwide, plans to substantially increase the number of CRAs as it continues to increase projects in large-scale global studies, the anticancer field, the central nervous system field, and other rheumatology fields.

  Responsibilities

  業務内容：
  MSLは、 担当する疾患領域における最新の科学知識に基づき、社外医科学専門家と同じ科学者同士の立場で医学的・科学的情報の交換並びに意見交換を通じて、アンメット・メディカル・ニーズを収集し、育薬に貢献することが主な役割です。
  具体的には、担当製品に関連する疾患・治療の国内外の最新情報を収集し、データの解釈や今後必要なデータ等について医療者と議論を行い、インサイト（知見）を得て、より安全な薬剤の使い方の検討や、より使いやすい薬剤への改善に活かします。
  これにより、治療の効率が上がったり、適応症（対象となる疾病）が増えたり、次の新薬開発のヒントを得ることで、薬剤価値の最大化を実現させることが主な業務です。
  そのほか、医療者からのリクエストに基づいた質疑対応や、臨床研究の相談窓口としての役割もあります。
  【具体的役割】
   KOL を訪問し、アンメット・メディカル・ニーズやメディカル・インサイトの収集
  主催、共催の講演会企画の立案、実行ならびに他部門の支援
  医療従事者からの非臨床、臨床研究等の相談対応
  Data generation plan の策定と戦略達成に必要なデータギャップの特定
  パブリケーションプランの作成
  

  

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• Job number: JN -072024-36297 Posted: 2024-09-11

  【在宅可】医薬品CMC・生産技術マネージャー

  原薬開発の経験ある方歓迎

  8 - 12 million yen Tokyo Pharmaceutical Regulatory Affairs

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  Company overview

  We are a pharmaceutical company specializing in the development and distribution of treatment drugs for rare diseases. Our goal is to bring smiles and happiness to patients and their families affected by rare diseases. We address challenges such as providing new treatment drugs, ensuring stable supply, improving diagnosis rates, and raising awareness of diseases. Additionally, we aim to expand sales through the handling of long-term listed products and the manufacturing and distribution of pharmaceuticals, ensuring the continued provision of new drugs. Our business includes the maintenance management of manufacturing and sales approvals, pharmaceutical manufacturing and sales operations, and sales management operations.

  Responsibilities

  ■業務内容：
  ＜新薬開発＞
  原薬／製剤の製造方法の評価、新規製造方法の開発～確立
  CDMOへの製造方法／分析方法の技術移管
  CMCパートのCTD評価、作成
  
  ＜既存品の維持＞
  CDMOの製造管理
  医薬品品目の承認事項一部変更承認申請に関するCTDの評価～作成
  
  ＜共通＞
  新規委託先の調査等
  
  ※海外出張あり（頻度：1回/2ヶ月程度）

  

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