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[Innovative Medicine] R＆D, Functional Manager for CRAs, Immunology Clinical Operation, GCO Japan

年収： 応相談 ?

採用企業案件

採用企業

ヤンセンファーマ株式会社

  • 東京都

    • 会社規模501-5000人
  • 医薬品メーカー
部署・役職名 [Innovative Medicine] R＆D, Functional Manager for CRAs, Immunology Clinical Operation, GCO Japan
職種
業種
勤務地
仕事内容 At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

■Position Summary:
Manager Clinical Operations is accountable for the operational management and successful country execution of all phases of clinical trials within assigned therapeutic area(s) or specific role(s), including resource allocation, adherence to timelines and budget, compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements. The Manager Clinical Operations supports TA Director and Country Head in shaping and managing local organizational structure to ensure its optimal efficiency and demonstrates effective issue management.

This individual is responsible for line management of Site Managers (SM) and/or other GCO staff, as required. Oversees staff performance, development, training, project assignments, workload distribution and supports issue resolution with direct reports. Ensures alignment of local goals with organizational objectives. Drives innovative solutions and process improvements for the assigned therapeutic area(s), country, and GCO/Global Development (GD) overall.

■Principal Responsibilities:
1. Provide line management to direct reports including setting goals and objectives, performance evaluation and talent development.

2. Evaluate and forecast resource needs for assigned portfolio and/or other specific area of responsibility, as required and agreed with local GCO management accordingly.

3. Responsible for deployment of the One Delivery Model through collaboration and oversight of vendors.

4. Accountable for the acquisition of new talents and development of human resources. 5 Guide direct reports in issue resolution and communication with involved stakeholders.

6. Lead organizational changes and effectively communicate on priority shifts as required.

7. Review and approve expenses in compliance with the company policies.

8. Demonstrate leadership behaviours in alignment with J&J Leadership Imperatives.

9. Foster an environment that encourages sharing of ideas, information and best practices (internal and external to the organization).

10. Provide coaching and mentorship as needed, including conduct of accompanied site visits as appropriate.

11. Define, execute or support of long term strategy in alignment with GCO, GD and JJIM R&D strategies to position the local and global GCO organization for success.

12. Oversight of execution and monitoring of clinical trials through all phases (from feasibility to close-out) and ensuring inspection-readiness within assigned therapeutic area(s) and/or other area of responsibility, as required.

13. Accountable for ensuring relevant operational objectives are met in conformance to ICH-GCP, relevant SOPs and other procedural documents.

14. Accountable for appropriate and timely issue escalation and reporting (suspicion) of fraud, scientific/ethical misconduct and health care compliance breach. Contribute to CAPA and issue resolution in accordance with required timelines.

15. Shape and maintain strong relationships within local GCO department and Local Operating Company (particularly with Medical Affairs) and other key internal and external stakeholders.

16. Develop country capabilities for an effective study placement within assigned therapeutic area(s) and/or other area of responsibility, as required.

17. Accountable for robust feasibility process and oversight of site selection to deliver on country commitments within assigned therapeutic area(s) and strategic goals.

18. Review operational and quality metrics regularly and drive follow-up actions as appropriate.

19. Drives innovative solutions and process improvements for the assigned therapeutic area(s), country, and GCO/GD overall. Foster a culture of continuous improvement and innovation within the local GCO team.

20. Model Credo based culture within the local GCO team.

This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.
応募資格

【必須（MUST）】

▪ Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).
▪ Minimum of 5 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site.

【歓迎（WANT）】

Budgeting, Clinical Trial Management Systems (CTMS), Clinical Trials, Compliance Management, Contract Management, Developing Others, Execution Focus, Fact-Based Decision Making, Inclusive Leadership, Laboratory Operations, Leadership, Process Improvements, Program Management, Project Integration Management, Research and Development, Research Ethics, Resource Planning, Team Management

▪ Effective communication and leadership skills. Ability to foster team productivity and cohesiveness.

▪ Effective issue resolution and ability to generate and implement contingency plans for both productivity and quality issues when required. Excellent knowledge of drug development, clinical research operations and regulatory requirements including ICH-GCP, HCC and applicable regulations. Ability to evaluate data generated from various reports and sources. Demonstrated skills in effective communication with various internal and external stakeholders (e.g. investigational sites, ethics committees, health authorities, etc.). Influential in improving the clinical research environment at a country level. Visionary leader who can shape the organizational culture to improve adoption of future state.

▪ Experience in mentoring/coaching (line management experience desirable). Proficient in decision-making and financial management.

▪ Flexible mindset and ability to work in a fast-changing environment. Operates under limited supervision. ▪ Proficient in English language. Computer literacy. Strong interpersonal and negotiating skills. Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner.
受動喫煙対策

屋内禁煙
更新日 2026/05/11
求人番号 8229496

採用企業情報

ヤンセンファーマ株式会社
  • ヤンセンファーマ株式会社

  • 東京都

    • 会社規模501-5000人
  • 医薬品メーカー

  • 会社概要

    私たちヤンセンファーマは、世界最大級のトータル・ヘルスケア・カンパニー、
    ジョンソン・エンド・ジョンソン（J＆J）グループの製薬会社として、いまだ
    満たされていない医療ニーズに迅速に応え、最先端の医薬品を一刻も早く患者
    さんの手元に届けることができるよう取り組んでいます。

    私たちは、世界57ケ国200社以上に及ぶJ＆Jグループを貫く経営理念「我が信条
    （Our Credo）」を志とし、さらに、46年間に84品目もの新薬を開発したヤンセ
    ン・ファーマスーティカ社の創業者、ポール・ヤンセン博士の妥協なき開発精
    神を継承し、J＆Jグループの優れた新薬の導入はもちろん、医療現場への適切
    かつ最新の医療情報の提供、さらには、患者さんのＱＯＬ（クオリティ・オブ・
    ライフ）の向上を目指した支援活動などをおこなっています。

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