Purpose Statement:

Bring impactful medicines to patients as quickly and efficiently as possible, working as one with global teams to deliver the most competitive asset strategies

当該治療領域において、最も競争力のある開発戦略をグローバルチームと一体となって策定し、画期的な治療を可能な限り早くかつ効率的に患者さんに届ける

結果責任 / Responsibilities

• Defines and executes a development strategy for Japan for individual asset programs which contributes to sustainable, successful growth of Abb Vie GK
• Ensures that the individual development assets add significant value to Abb Vie GK, through effective, rapid and broad development of pipeline assets, with adequate consideration of market access, medical and commercialization aspects
• Takes a holistic and strategic approach to maximize performance of Japan Asset Strategy Teams by leading, driving and coordinating all development activities for Japan
• Foster continuous improvement mindset as one team from learnings throughout asset lifecycle

役割 / Role

Develop an integrated development strategy for Japan

• Creates the most competitive strategy based on regulatory requirements and commercial needs
• Brings new products to the market through fastest and cost-optimized approach
• Provides inputs to Asset Strategy Team (AST) ensuring Japan development strategy is integrated into the global development strategy
• Ensures alignment on the program development strategies within Japan Asset Strategy Team (JAST) and with relevant stakeholders including governance bodies in Japan (e.g. Therapeutic Area Review Meeting, Japan NPI) and AST
• Represents JAST at ASTs and the appropriate decision bodies in Japan

Lead the Japan Asset Strategy Team:

• Sets challenging individual asset-related objectives for and together with cross-functional team members to be considered in team member’s objective setting
• : Fosters trust and transparency within the cross-functional team and works to maximize engagement to optimize team functioning
• For asset-related activities, provides regular feedback and coaching to team member concerning their contribution to the team performance and target objectives

Is accountable for advancing assets on time, in (external) budget and required quality

• Defines and plans development timelines and milestones in alignment with JAST members, key bodies in Japan and AST
• Drives and steers the implementation of the asset strategy in Japan, by leading JASTs and cooperating with ASTs.
• Proactively develops proposals to manage/mitigate/resolve risks for a project in Japan.
• Holds JAST members responsible for committed timelines and budgets in Japan

For Grade 18 JASL

• Leads large, complex, highly visible, multi-indication asset and/or a suite of assets across multiple stages of development or franchise
• Able to actively influence, shape and drive cross-functional decision-making of high priority, complex programs
• Build strong connections to the global Asset Strategy Leadership group, proactively influencing global development strategy from affiliate perspective
• Represents excellence in Japan Asset Leadership. Coaches and mentors less experienced JASLs

Expected hiring grade:

• 17 or 18 (Offering position will be determined based on the career experience and evaluation)

Background/Experience / 経験／職歴

At least 5 years in clinical development and experience of one or more NDAs, or equivalent knowledge.

臨床開発経験が5年以上、1品目以上の新薬申請業務経験、もしくはそれに相当する臨床開発知識があること

Development experience for assigned multiple therapeutic areas, or equivalent knowledge.

複数の担当疾患領域における開発経験がある、もしくはそれに相当する臨床知識があること
Education / 学歴

Graduate from Medical School, College of Nursing, College of Pharmacy, College of Science/Agriculture, or life-science course (Holder of master degree or PhD degree is preferable), or equivalent education

医学部、薬学部、看護学部、理学 / 農学部、もしくは生命科学系の大学学部卒かそれ以上（修士、博士号保持者はなお可）

Preferred, holder of Medical Doctor, Veterinarian, Pharmacist, or other related with life-science related degree or license

医師、獣医師、薬剤師等、生命科学に関連する学位・免許取得者が望ましい

Leadership Behavior/Mindset

• Set Vision ビジョンと戦略を設定する
• Anticipate 将来を予見して行動する
• Innovate 革新を促す
• Build 築き上げる
• Deliver Results 確実に成果をもたらす

Knowledge 知識

Sufficient knowledge regarding process of NDA and approval from making clinical development plan (PMDA consultation, Protocol preparation, Study management, CTD preparation, response to PMDA queries after NDA etc.)

臨床開発計画作成から申請・承認（PMDA相談、プロトコル作成、試験の管理、申請資料作成、照会事項対応等）に関する十分な知識

Sufficient knowledge in the therapeutic area assigned

担当分野に関する十分な知識

General knowledge of pharmaceutical association (Seiyaku kyo and Pharma etc.).

業界（製薬協、Pharma）に関する一般的知識

The latest guidelines and regulations (GCP etc)

最新のGuidelines、法令（GCP等）に関する知識

TOEIC score is 850 or higher, or equivalent skill for English communication.

TOEIC 850点以上、もしくはそれに相当する英語コミュニケーション力
Skill スキル

• Leadership リーダーシップ
• Coaching コーチング
• Team building チームビルディング
• Communication skill with both of Japanese and English コミュニケーションスキル（日本語、英語）
• Facilitation Skill ファシリテーションスキル

アッヴィは、機会均等を重視する雇用主であり、誠実な企業活動、革新の推進、人々の生活への貢献、そして地域社会への貢献に努めています。雇用機会均等に向けて、障がいを持つ方々も積極的に支援しています。

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.