[Janssen] R&D, Clinical Operations Director (Non-Oncology), Global Clinical Operations Japan

Position Summary:

This position is accountable for strategic and operational management of clinical research and development activities in Japan. This leads to successful execution of all phases of clinical trials for responsible therapeutic area, including resource allocation, adherence to timelines and budget, compliance with relevant Standard Operating Procedures (SOPs), policies, Health Care Compliance (HCC) and local regulatory requirements. This position shapes and manages local organizational structure to ensure its optimal efficiency and demonstrates an effective issue management within the country and across countries. This role is responsible for line management of Functional Managers and other GCO Japan staff, as required. Ensures alignment of local goals with organizational objectives. Drives innovative solutions and process improvements for the country/region or GCO/ Global Development (GD)/JJRD overall.

Principal Responsibilities:

1. Define and execute long term strategy in alignment with JJRD, GD and Janssen R&D strategies to position the country for success.

2. Accountable for attracting, planning, execution and monitoring of clinical trials through all phases (from feasibility to close-out) and ensuring inspection-readiness in the country.

3. Ensure all operational objectives are met in conformance to ICH-GCP, local regulations, relevant SOPs and other procedural documents.

4. Accountable for an appropriate and timely issue escalation and reporting (suspicion) of fraud, scientific/ethical misconduct and health care compliance breach.

5. Primary point of contact for Health Authority agencies for activities related to clinical operations.

6. Country legal representative for GCO related activities (authorized to sign contracts and agreements except for GCO Japan head responsibility).

7. Accountable for functional budget and affiliate funding in compliance with relevant financial processes.

8. Shape and maintain strong relationships within GD and Local Operating Company (particularly with Medical Affairs). Might participate in Local Operating Company Management Board and Regional Management Teams.

9. Develop country capabilities for effective study placement.

10. Oversee selection of sites to deliver on country commitments and strategic goals.

11. Ensure the country compliance with quality and operational metrics. Lead regular metrics review and necessary follow-up actions.

12. Contribute to development and evaluation of new processes and standards to improve clinical trial management as well as lead their rollout in the country.

13. Ensure adequate quality oversight in the country.

14. Ensure compliance to safety reporting requirements in the country.

15. Foster a culture of continuous improvement and innovation within the local GCO team.

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

17. Contribute to shaping environment for clinical trials in the country (e.g. through involvement in pharma industry associations).

18. Provide line management to direct reports including setting goals and objectives, performance evaluation and talent development.

19. Evaluate and forecast overall resource needs for the country.

20. Ensure an efficient utilization of flex model at the country.

21. Interview, hire, develop and train staff.

22. Ensure understanding of relevant processes and procedural documents supported by documentation of staff training compliance as required.

23. Lead organizational changes and effectively communicate on priority shifts.

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

25. Strongly demonstrate leadership behaviors in alignment with J&J Leadership Imperatives.

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

27. Provide coaching or mentorship as needed.

Principal Relationships:

Primary Reporting Structure: Reports to GCO Japan Head.

Primary interfaces: Functional Managers including CRMs, JJRD LTs, other Local R&D Heads in cluster/region and other GCO Japan staff in the country.

Other Internal Interfaces: R&D/Local Operating Company staff (including Medical Affairs), departments within and outside of GCO/GD, i.e. Central Trial Management, Portfolio Delivery Operations, EBIS, IDAR, BRQC, HCC, External Alliances, Contracts and Grants and others as required.

External Interfaces: Functional management of flex providers, Health Authorities, local pharma industry associations, investigational sites, local vendors and others as required.