■職務内容
• 日本におけるプログラムの責任者として、目標・計画・意思決定・成果物を明確にし、達成に向けた最終責任を担います。
• グローバル戦略に基づき、日本市場におけるプログラムの方向性の設定および推進を担当します。開発・LCM戦略の立案や目標設定、計画実行に携わります。
• 担当プログラムの計画遂行と重要なマイルストーンの達成を管理します。
• 日本での開発開始からライフサイクルマネジメントまで、前臨床、CMC、臨床、LCMなど関連する活動全般に責任を持ちます。
• JPTを率いて、プログラム計画のレビューや改善を実施します。
• プログラム関連の目標設定、コアメンバーの評価に貢献します。
• APJ上級管理職に常に情報を共有します。
• プログラムの予算管理を行います。
• チーム力の最大化と維持に努めます。
• 他領域担当のJPTLとの連携・教育・協働にも取り組みます。
■応募資格
• 複数の臨床試験(CTN)を含むプロジェクト管理経験、臨床試験運営、CSR/CTD作成、J-NDA申請、PMDAコンサル対応など、包括的なリーダー経験が望まれます。
• 医薬品・バイオ医薬品・バイオテクノロジー分野で10年以上の医薬品開発経験がある方。
• 品質、卓越性、効率性を重視し、少なくとも一つの開発品をリードした実績がある方。
• グローバルかつマトリックス型の組織で医薬品開発プロジェクトや活動を主導した経験。
• 国内外のメンバー・関係者・科学者・他企業との交流や協働に関する幅広い理解。
• 規制、科学、商業面での環境変化への対応力。
• データ解析力、分析力、高い判断力を持ち合わせている方。
• 現実的なビジネス期待を持ち、組織内外との連携もできる方。
• 勤勉で、結果重視の姿勢を持つ方。
• 短期的な困難に対しても粘り強く取り組み、長期的視点で成果を追求できる方。
• 医薬品開発に必要な幅広い学際的知識、CMC、薬理・毒性、PK、主要な規制提出に対応できる臨床要件の理解。
• 戦略的課題を特定し、PMDA等マイルストーン会議の準備・主導経験がある方。
• CMC、Pharm/Tox、PK、臨床、薬事、マーケティング、財務など多領域の連携(時間・リスク・コストの観点も含む)について国内外で理解がある方。
• 規制ガイドライン、社内SOP、プロジェクトベストプラクティスへの教育・助言・運用について十分な知識と経験がある方。
■学歴
• 薬学学士または理系修士以上、または指定領域に関連する臨床開発経験をお持ちの方。
■求めるコンピテンシー
• 説明責任:危機感をもって迅速に行動できる方
• 協調性:メンバー全員の力を引き出し、活用できる方
• 意思決定:分析・知見・経験を活かし、迅速かつ的確に判断できる方
• 忍耐力:エネルギッシュに物事へ取り組み、最後までやり遂げる力のある方
• 問題解決力:潜在的な課題を発見できる方
• 結果志向:高い目標を設定し、達成やそれ以上の成果にこだわれる方
• リーダーシップ:チームメンバーの成長を支援し、魅力ある組織づくりができる方
• オープンマインド:前向きな姿勢でチームを鼓舞し、コミュニケーションを通じて楽観的な雰囲気を作れる方
Date Posted
11-9月-2025Closing Date
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact Alexion participates in E-Verify.
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