By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description INTRODUCTION（はじめに） Marketed Products Medical & Development（MPMD）not only fulfills its responsibilities as a marketing authorization holder by providing scientific expertise and leadership but also ensures that patients around the world have access to Takeda’s products by maximizing their value. MPMD Japan primarily leads and manages clinical development projects for post-marketing products. Marketed Products Medical & Development（MPMD）は、科学的専門知識とリーダーシップを提供することで、製造販売業者としての責務を果たすだけでなく、タケダの製品の価値の最大化を通して、世界中の患者さんが我々の製品にアクセスできるようにしています。MPMD Japanは主に市販後製品の臨床開発プロジェクトのリードやマネジメントを担う部門です。 Responsibilities（職務内容） Provide medical and clinical scientific leadership for regional development activities 地域の開発活動に対して、医学的・臨床科学的なリーダーシップを発揮する Design and oversee clinical research studies that support clinical and business goals 臨床面・事業面の目標を支える臨床試験を計画し、監督する Provide strategic direction and oversight to managers across multiple functional areas from Clinical Science perspective 各開発部門に対してSCの観点から戦略的な方向性を示し、監督する Serve as the main contact for contracts and operations across internal and external partners 社内外のパートナーにおける契約および業務の主たる窓口を務める Build working relationships with clinical experts and relevant partners 臨床専門家および関連するパートナーとの協力関係を構築する Lead briefings and technical meetings with peer managers 同等職位のマネージャーとのブリーフィングおよび技術的会議を主導する Interpret complex clinical data to support drug or device approvals 複雑な臨床データを解釈し、医薬品または医療機器の承認や適応拡大を支援する Manage safety protocols and address safety issues in clinical trials 安全性プロトコルを管理し、臨床試験における安全性の課題に対応する Craft organizational policies that support clinical development strategy 臨床開発戦略を支える組織方針を策定する Oversee projects and implement clinical development strategies プロジェクトを監督し、臨床開発戦略を実行する Represent the organization as a medical expert in interactions with regulatory authorities 規制当局とのやり取りにおいて、医学専門家として組織を代表する Set realistic budgets, schedules, and performance standards, and monitor progress against them 現実的な予算、スケジュール、パフォーマンス基準を設定し、それらに対する進捗をモニタリングする Promote collaboration across the team チーム全体の協働を促進する Handle multiple projects while maintaining compliance and safety standards コンプライアンスおよび安全基準を維持しながら、複数のプロジェクトを担当する Collaborate with regional business units to align clinical strategies and support due diligence and business development assessments 地域の事業部門と連携して臨床開発戦略を整合させ、デューデリジェンスおよび事業開発の評価を支援する Skills and qualifications（スキルおよび資格） Medical Doctor degree 医師免許（医学博士号）を有すること Japanese proficiency with business-level or higher English communication skill 日本語に堪能で、ビジネスレベル以上の英語コミュニケーション能力を有すること At least 5 years of experience in clinical science, clinical research, or related drug or device development work 臨床科学、臨床研究、または関連する医薬品・医療機器開発業務において5年以上の経験 Pharmaceutical industry or CRO experience in clinical development in Japan 日本における臨床開発での製薬企業またはCROでの経験 Strong knowledge of medical science and how it applies in a commercial setting 医科学および、それを商業的場面でどのように活用するかについての深い知識 Experience providing strategic direction and oversight to teams or managers チームまたはマネージャーに対して戦略的方向性を示し、監督した経験 Strong knowledge of ICH-GCP and understanding of Japan regulatory requirements and compliance expectations ICH-GCPに関する深い知識、および日本の規制要件とコンプライアンス上の期待事項への理解 Experience with Japanese regulatory submissions, including New Drug Applications, is preferred 新薬承認申請（NDA）を含む、日本の規制申請の経験があれば尚可 Experience in oncology clinical development is highly preferred オンコロジー領域の臨床開発経験 Experience designing clinical studies and interpreting complex clinical data, including evaluating AI-enabled tools and digital innovations for appropriate use in clinical research 臨床試験の計画および複雑な臨床データの解釈の経験（臨床研究におけるAI活用ツールやデジタル革新技術の適切な利用の評価を含む） Experience managing safety protocols and clinical trial safety issues 安全性プロトコルおよび臨床試験の安全性課題を管理した経験 Ability to work with key opinion leaders and senior internal and external contacts キーオピニオンリーダー（KOL）および社内外の上級職の関係者と協働できる能力 Experience leading contracts and operations discussions at a senior level undefined Experience developing policies, setting priorities, and supporting cross-functional work 方針の策定、優先順位の設定、部門横断的な業務の支援の経験 Ability to oversee several projects at once while meeting quality, safety, and compliance expectations 品質、安全性、コンプライアンスの期待事項を満たしながら、複数のプロジェクトを同時に監督できる能力 Leadership scope（リーダーシップ） As a leader of a sizable functional area, serving as the primary internal and external contact for contracts and operations, your responsibilities include conducting high-level briefings and technical meetings, interacting with managers of equivalent status, and crafting corporate and organizational policies. You will provide strategic direction and oversight to managers across various functional areas, prioritizing the successful execution of major initiatives and ensuring that budgets, schedules, and performance standards are both realistically established and achieved. Your role focuses on strategic impact rather than day-to-day operational involvement. クリニカルサイエンスのリーダーとして、契約および業務に関する社内外の主たる窓口を務め、各種会議の実施、同等職位のマネージャーとの折衝、全社・組織の方針の策定を担います。さまざまな領域のマネージャーに対して戦略的な方向性を示して監督し、予算、スケジュール、パフォーマンス基準を現実的に設定し、達成する。 The role requires the ability to influence without direct authority, achieve alignment across multicultural and cross-functional teams, and represent Japan and Asia perspectives in global portfolio and development decisions. It also includes mentoring Associate Medical Directors and other Clinical Science colleagues and strengthening clinical development capabilities across the region. 本職務では、直接的な権限を持たずに影響力を発揮する力、多文化・部門横断的なチーム間で合意形成を図る力、そしてグローバルのポートフォリオおよび開発の意思決定において日本およびアジアの視点を代表する発信能力が求められます。また、アソシエイト・メディカル・ディレクターやその他のクリニカルサイエンスの指導、地域全体の臨床開発力の強化も含まれます。 Takeda Compensation and Benefits Summary: Allowances: Commutation, Housing, Overtime Work etc. Salary Increase: Annually, Bonus Payment: Twice a year Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45 Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year) Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave. Flexible Work Styles: Flextime, Telework Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc. Important Notice concerning working conditions: It is possible the job scope may change at the company’s discretion. It is possible the department and workplace may change at the company’s discretion. Locations JPN - Osaka - Osaka Headquarters Worker Type Employee Worker Sub-Type Regular Time Type Full time Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer. For applicants of U.S and Puerto Rico positions: Click here to learn about our commitment to Equal Employment Opportunity (EEO). If you are limited in the ability to use our job application tool, or otherwise require a reasonable accommodation for a disability please click here.

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