治験薬サプライチェーン担当者 / Investigational Drug Supply Chain Specialist

職務内容／Job duties

募集背景

中外製薬は自社の革新的創薬技術に加え、ロシュグループの豊富なパイプラインを有しており、多くの治験が実施中です。

治験実施には「治験薬の計画的・安定的供給」が不可欠であり、この責任者を担う治験薬サプライチェーン担当者は臨床開発Study team memberの一員として大変重要な役割を担っています。

近年、治験数の増加やモダリティの多様化への対応等、最適なプロセスの再構築・E2Eのシステム導入にも取り組んでおり、治験薬供給および関連プロセスの改善活動に貢献できる即戦力となりえる人財を求めています。

仕事内容

• 治験薬サプライ機能としてE2E（中間体・原薬・製剤製造拠点、包装・国内外配送デポ・治験実施医療機関）を通じ、立案した供給計画に基づき、CMC/臨床機能関係者、海外拠点や国内外CMOと協力しながら、供給を構築・推進し、On-Time In-Full供給を実現する。また、それに関わるサプライチェーンシステムを運用する。
• バルク包装以降の供給計画を治験薬開発計画や臨床機能からの所要計画に基づき立案し、治験薬ラベル文書を執筆、供給に関する情報を臨床開発Study teamに提供する。
• CMOへの発注・基本契約締結、輸送・輸出入、保管デポ入庫、有効期限延長・短縮、異常逸脱、未使用治験薬の廃棄、リコール、監査等の対応、予算・請求書支払い、CMO・デポのオーバーサイト等の周辺業務を行う。
• 最新の規制や業界のベストプラクティスの入手に努め、治験薬サプライ業務プロセスの最速かつ最適な再構築提案を行い、臨床開発スケジュール・コストへの貢献を図る。

職種の魅力：

自社およびロシュの豊富な開発パイプライン、新たなモダリティ等があり、多種多様な治験薬管理の経験を得ることができ本領域における専門性スキルの向上が期待できます。

ロシュや海外拠点の治験薬担当と連携し、グローバルレベルな治験薬マネジメント業務をリードすることで治験推進に貢献できます。

First in class、Best in classの薬剤開発に貢献でき、新薬承認、世界の健康に貢献できることで社会への貢献を実感できます。

Background to recruitment:

In addition to its own innovative drug discovery technologies, Chugai Pharmaceutical has access to the Roche Group's extensive pipeline and is conducting numerous clinical trials.

The planned and stable supply of investigational medicinal products is essential to conducting clinical trials. The investigational drug supply chain specialist responsible for this work plays a critical role as a member of the clinical development study team.

In recent years, we have also been redesigning optimal processes and implementing end-to-end systems to respond to the growing number of clinical trials and the diversification of modalities. We are seeking an experienced professional who can make an immediate contribution to investigational drug supply and related process improvement initiatives.

Description of work:

• As part of the investigational drug supply function, establish and manage end-to-end supplyーfrom intermediate, drug substance, and drug product manufacturing sites through packaging, domestic and international distribution depots, and clinical trial sitesーin accordance with established supply plans. Collaborate with CMC and clinical stakeholders, overseas sites, and domestic and international CMOs to achieve On-Time In-Full delivery, and operate the related supply chain systems.
• Develop supply plans from bulk packaging onward based on investigational drug development plans and demand forecasts provided by clinical functions; prepare investigational drug labeling documentation; and provide supply-related information to clinical development study teams.
• Manage related activities, including placing orders with CMOs, executing master agreements, transportation, import/export, receipt at storage depots, shelf-life extensions and reductions, deviations, disposal of unused investigational drugs, recalls, audits, budget and invoice payments, and oversight of CMOs and depots.
• Stay current with the latest regulations and industry best practices; propose the fastest and most effective redesign of investigational drug supply processes; and contribute to clinical development timelines and cost optimization.

Position Features:

With Chugai's and Roche's extensive development pipelines and emerging modalities, you will gain experience managing a wide variety of investigational medicinal products and have opportunities to deepen your expertise in this field.

By collaborating with investigational drug supply teams at Roche and other overseas sites and leading global investigational drug management activities, you can contribute directly to the advancement of clinical trials.

You will also help develop first-in-class and best-in-class medicines and experience the fulfillment of contributing to new drug approvals and better health worldwide.

応募資格／Qualifications

求める経験：

• CMC開発、臨床開発（製薬企業、CRO）、CMOいずれかの経験があることが望ましい
• 複数の治験プロジェクトもしくは大型プロジェクトを担当し、業務を完遂した経験
• 自部門内外の複数部署、社外の外部のステークホルダーと協働し、プロジェクトを代表して交渉・折衝を行った経験

さらに以下の経験や実績があると尚可

• 臨床試験計画に従った治験薬必要量の計画策定経験
• 治験薬サプライ業界情報、治験薬関連のVendor等の豊富な知識

求めるスキル・知識・能力：

• 治験薬サプライ関連のGMP、GCP、GDPを含む国内外規制を理解し、自らの業務に落とし込んで説明できる方
• 担当業務を適切な時期に確実に実行し、関係者と円滑に業務を遂行することができる方
• トラブルに対し、迅速かつ能動的に良好な関係構築を築きながら本質的なポイントを抑え、効果的な改善策・課題解決の立案・実行を行うことができる方
• 課題に対する論理構築力とコミュニケーション能力。さらにその内容を相手にわかりやすく説明できる言語化、プレゼンテーション能力

求める行動特性：

• 患者さん目線で行動できる

チームおよび個人の目標へのコミット意識が高く、目標達成に向けて困難があっても遂行責任を負って粘り強く邁進し自走することができる

• 高い倫理観を持ち、常に誠実な行動で様々な社内外ステークホルダーと友好的な協力関係を築き、互いのWin-Winを常に意識し、課題抽出、解決策を立案・実行できる
• 新たな取り組みに積極的に参加し、挑戦する

必須資格：

• 英語でのビジネスコミュニケーションが可能な方（TOEIC 730点以上程度）

Desired experience:

• Experience in CMC development, clinical development (at a pharmaceutical company or CRO), or CMO operations is preferred.
• Experience successfully managing multiple clinical trial projects or a large-scale project through completion.
• Experience collaborating with multiple internal departments and external stakeholders, and negotiating on behalf of a project.

[The following experience and achievements are additionally preferred]

• Experience planning investigational drug requirements in accordance with clinical trial plans.
• Extensive knowledge of the investigational drug supply industry and related vendors.

Preferred Knowledge and Skills:

• Ability to understand domestic and international regulations related to investigational drug supply, including GMP, GCP, and GDP, apply them to your work, and explain their practical implications.
• Ability to execute assigned responsibilities reliably and at the appropriate time while working smoothly with stakeholders.
• Ability to respond to problems quickly and proactively, identify the essential issues while building positive relationships, and develop and implement effective improvements and solutions.
• Logical thinking and communication skills for addressing business challenges, along with the ability to articulate ideas clearly and present them in an easy-to-understand manner.

Desired competencies:

• Ability to act from a patient-centered perspective.
• Strong commitment to team and individual goals, with the ability to take ownership, persevere through difficulties, and work autonomously toward achieving objectives.
• High ethical standards and integrity; ability to build cooperative relationships with diverse internal and external stakeholders, maintain a win-win mindset, identify issues, and develop and implement solutions.
• Actively participate in and embrace new initiatives and challenges.

Desired Qualification:

• Ability to communicate effectively in English in a business environment (approximately TOEIC 730 or above).
• Japanese Language Proficiency Test Level N2 or above, or equivalent Japanese language ability

待遇／Salary & Benefits

フレックスタイム制（コアタイムなし）

Flextime system

当社規定により優遇いたします。

労働条件の通知は電子ファイルによって行います。ご応募される場合は、その点につきご了承ください。

To be decided in accordance with our criteria.

The notification of working conditions will be made in an electronic file. If you apply, please understand this point.

勤務地／Location

浮間研究所（東京都北区）/ Ukima Research Laboratories (Kita Ward, Tokyo)

事業所内禁煙

就業時間内禁煙（※）