転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です
| 部署・役職名 | Strategic Partnership Manager/ノンラインマネージャー/医薬開発本部クリニカルディベロップメントオペレーションズジャパンローカルベンダーマネジメント |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
【Basic purpose of the job】 The Strategic Partnership Manager （Local/Regional Partnership Manager in Global） contributes to the Clinical Research Organisation （CRO） strategic partnership , ensuring the multiple complex interfaces are seamless and efficient and that pipeline commitments are delivered with maximum speed and highest customer value. Provides direction and leadership in Japan while representing the Global Vendor Management Network. Responsible for the CRO strategic partnership engagements in Japan, including oversight of quality, performance of the CRO, contractual and financial oversight, as well as continued enhancement of the CRO strategic partnerships relationships. Contributes and ensures execution of the global vendor management strategy in Japan in alignment with the Company Priorities. This position will collaborate closely with the Delivery Model Team in CDO partnerships – CD＆O Regions, the CRO, and other local and global functions to ensure a successful partnership that drives clinical development excellence. 【Accountabilities － Related performance indicators】 ・In alignment with the OneHP strategic priorities, Medicine Excellence goals and CDO priorities, implements, oversees, and maintains the strategic CRO partnership and operating model in Japan. Ensures strong collaboration with both Global CDO and CRO that drives excellence in operations and delivery of pipeline commitments for CDO. Evidence of effective contribution, oversight and delivery of operational aspects of the Strategic CRO Partnership model aligned to the One Medicine visions （including goals, risk mitigation）. ・Leads vendor governance process for respective Japan with CDO Japan and internal stakeholders. Lead and conducts regular governance meetings with CRO and stakeholders in Japan focusing on operational delivery, quality, contractual and financial oversight. Evidence of effective governance, oversight, issue resolution, and CRO performance. ・Assesses CRO performance collaboration stakeholders in Japan against internal and external benchmarks and KPIs. Provides R/OPU performance feedback to the Partnership Lead of Delivery Model in CDO Partnerships – CDO Regions. Maintenance and monitoring of defined KPIs and evidence of follow－up on CRO KPIs that are underperforming. ・Accountable for CRO issue resolution in Japan in accordance with the CRO operating model and governance. Manages CRO issue escalation and resolution process in Japan to drive delivery of appropriate execution and delivery of clinical studies on time. Evidence of effective CRO issue resolution in Japan with appropriate escalation to Global CDO 【JOB PROFILE】 Leads and oversees onboarding of vendor staff to ensure timely access to BI systems to meet trial commitments in Japan. Co－develops tools, processes and instructions aimed at continuously enhancing performance and service delivery in Japan. Support local QM during internal and regulatory audits and inspections Defines the scope and specifications of services required from CRO in Japan in collaboration with the different stakeholders. Provides CRO with projected requirements in Japan to ensure timely and appropriate allocation of skilled resources. Responsible for ensuring appropriate resources are available from CRO for current and planned projects in Japan. Collaborates closely with the Delivery Model Team in CDO Partnerships on the FSP work order and change order process to ensure the services are adequately covered in Japan, and appropriate contracting is in place as required. Collaborates closely with Sourcing for purchasing activities in support of local/regional vendor engagements. Serves as the primary point of contact for the CRO within Japan. Manages communications regarding CRO assignments and trial changes impacting the deliverable of the service with the CRO including but not limited to, timelines, site numbers, issue identification, appropriate escalation, and resolution. Oversees CRO staff transitions ensuring, in collaboration with the CRO, sound transition plans are in place for business continuity. Liaises with the Partnership Lead of Delivery Model and leads training and change management activities related to the implementation of CRO operating model in Japan. Foster continuous improvement by monitoring industry trends and communicates information to the Partnership Lead of Delivery Model and local/regional management, including potential risks. Liaises with the Delivery Model Team for activities related to the implementation of local vendor engagement in Japan. Ensures qualification activities are completed and oversight plans are in place per Medicine procedures. Timely access of CRO’s staff to BI’s processes and systems. Delivery of services meets CDO clinical trial commitments in Japan. Supports the Partnership Lead of Delivery Model, by defining proper oversight measurements to foster an environment of continuous improvement for Japan. Evidence of continuous improvement and relationship with CRO for activities in Japan. Fosters a learning culture in Japan by encouraging continuous learning, sharing best practices, learning from failures. Embraces innovative technologies, as well as creates and maintains a culture that inspires and motivates, drives empowerment, smart risk taking and one common CD＆O identity. Ongoing leadership to internal stakeholders. 【Regulatory and / or Organisational Requirements】 Adherence to national and international regulatory and legal rules. Ensures all tasks are carried out in accordance with respective applicable BI SOPs, BI Business Practices, HTGs and regulatory requirements. Ensures that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality, in accordance with BI values and a focus on speed and patient value. 【Job Complexity】 Medium to high complexity due to interdisciplinary interfaces in Japan, Corporate CDO functions, CRO Strategic partners in Japan. Critical thinking is required in order to formulate decisions with diverse information, and complexities associated with local regulatory and ethical requirements associated with the clinical development process. 【Internal to BI】 • Corporate the Partnership Lead of Delivery Model ＆ Vendor Management Network • Japan ＆ Global Enabling functions including but not limited to Finance, Legal, and Sourcing • CDO Japan personnel （CTM, Head of Local Vendor Management, HCO, enabling functions） • Quality and Compliance in Japan External to BI: • CROs in Japan 【Job Expertise】 • Professional experience/ knowledge relevant to clinical operations, which preferably will have been acquired in the context of vendor management principles and practices, either on the sponsor or on the vendor side • Experience in Therapeutic Areas relevant in BI pipeline is desirable • Comprehensive knowledge of the company strategy of one’s own organizational unit to the corporate goals • Ability to execute strategy • Demonstrated Our Behaviors • Long－standing working experience in international context and cross functional work 【Job Impact】 Steering of the CRO operating model in line with Company’s One Medicine vision we aim to deliver Clinical Trials focusing on an improved patient and site experience, BI to be recognized as a patient ＆ site centric company and hence a preferred clinical trial sponsor of choice, turning quality insights into informed clinical development and informing future business decisions. Management and influence of a broad spectrum of internal and external stakeholders across all R/OPUs and corporate CDO. Contributes to the execution of the Strategic CRO partnership ＆ operating model within CDO in Japan by providing leadership, oversight, operational coordination and alignment,. Decision making and risk taking based on diverse and complex sources of information. Provides oversight based on regulatory requirements （e.g., ICH E6 R3） as well as being a key and trusted advisor to provide guidance and perspective of vendors. |
| 労働条件 |
契約期間：期間の定めなし 試用期間：あり（3カ月） 就業時間：8:45～17:20（うち休憩45分間） 休日：土日、祝日 その他各種会社休日あり（年間127日：2025年） 休暇：年次有給休暇（入社初日に6～16日を付与）、慶弔休暇・リフレッシュ休暇等各種有休特別休暇制度あり 残業：あり 給与改定：年1回（4月） 通勤手当：会社規定に基づき支給 社会保険：健康保険、厚生年金、労災保険、雇用保険 |
| 応募資格 |
【必須（MUST）】 【学歴・ご経験】・大学卒以上、またはそれに相当する専門的な職務経験 ・専攻分野：ライフサイエンス領域 または ビジネス関連 ・製薬業界または CRO における臨床オペレーションに関連する経験 ・5年以上の臨床研究経験 ※特にベンダーマネジメント または 臨床アウトソーシング業務 に重点を置いた経験が望ましい 【強力なコミュニケーションスキル】 ・複雑なクロスファンクショナルなマトリックス組織（治験チームおよび拡張チーム）において、求められる行動・スキルを発揮できる ・事業戦略・計画を明確に説明し、継続的に方向性を合わせながら、言動の一貫性を保つ ・アクティブリスニングおよび文化的配慮を実践できる 【オペレーショナル専門性】 ・外部委託されたさまざまなワークパッケージにおいて、治療領域の知識と運用面での専門性を示すことができる ・リーダーシップと影響力 ・複雑な状況に対応し、チームの方向性を自信を持って示す能力 ・チームを支え、つなぎ、エンパワーし、将来の方向性を提示するリーダーシップを発揮 ・先見性と革新的な思考を示し、共通の目標達成に向けてチームを鼓舞できる ・常に患者価値の提供を目的として活動する 【戦略的思考】 ・将来を見据えた戦略的・ビジョナリーな思考を持ち、創造的かつ果敢に行動し、不確実性を乗り越える能力 ・クロスファンクショナルな取り組みに積極的に関わり、革新的な学びを応用する ・結果志向であり、グローバルな視点からリスクとメリットのバランスを取りつつ、分析に基づいた解決策を導き出す 【カスタマーバリュードライバー】 ・顧客と積極的に関わり、強固な関係を築き、顧客中心のソリューションを提供する能力 ・コーディネーションとオーバーサイト ・優先順位の設定、活動ペースの管理、リソースの効率的活用に関するスキルを持つ協働的な個人貢献者 【財務スキル】 ・主要な財務指標を理解し、それを業務上の意思決定に適切に応用できる能力 【効果的なクロスファンクショナルコラボレーション】 ・組織内外で関係・提携・連携を構築・維持し、情報・支援・協力を得る能力 【好奇心と革新的思考】 ・新しい知識や情報を求める強い意欲、探究心、興味関心を持つ 【デジタルリテラシー】 ・デジタル環境において、情報アクセス、創造性、問題解決、コミュニケーション、ナビゲーション、学習、応用などの技術を活用できる能力 【英語力】 ビジネスレベル（SpeakingとWriting） CEFR B2 レベル以上の英語スピーキング能力 |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2026/03/30 |
| 求人番号 | 7891759 |
採用企業情報
- 企業名は会員のみ表示されます
- 会社規模501-5000人
この求人の取り扱い担当者
-
- ヘッドハンターの氏名は会員のみ表示されます
会社名は会員のみ表示されます
-
- IT・インターネット メーカー メディカル
-
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です