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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.

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Project Management:

Job Category:

Professional

All Job Posting Locations:

Chiyoda, Tokyo, Japan

Job Description:

Position Summary:

Director Clinical Operations/Director Clinical Operations TA Head 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 Director Clinical Operations/Director Clinical Operations TA Head supports Country Head in shaping and managing local organizational structure to ensure its optimal efficiency. This individual is responsible for line management of Functional Managers (FM)/Clinical Research Managers (CRM), 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.

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).

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

17. Oversight of feasibility process and 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.

Principal Relationships:

Primary Reporting Structure: Reports to Country Head or equivalent

Primary interfaces: Country Head, other Director Clinical Operations/Director Operations TA Head, Program Delivery Leaders (PDL)/Trial Delivery Leaders (TDL), Strategic Account Leads (SAL) and supporting roles in the country.

Other Internal Interfaces: Local Trial Managers (LTM), Site Managers (SM), Clinical Trial Assistants (CTA), R&D/Local Operating Company staff (including Medical Affairs), departments within and outside of GCO/GD, i.e. Delivery Units (DU), Integration and Process Optimization, Integrated Data Analytics & Reporting (IDAR), BRQC, HCC, External Alliances, Contracts & Centralized Services (CCS) and others as required.

External Interfaces: Functional management of relevant vendors, Health Authorities, Ethics Committees, investigational sites, local vendors and others as required.

Education and Experience Requirements:

• Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).

• Minimum of 10 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site.

• Excellent communication and leadership skills. Proven ability to foster team productivity and cohesiveness. Ability to manage complexity under pressure.

• 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.

• At least 4 years of line management experience required. 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.

＜ For Internal Applicants＞

• If you are Japan employee, please read “Internal Application Guideline” in Ask GS. Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR. If you are Japan’s employee, you are not able to apply for multiple positions at once.

• For Employee Referral Program (ERP), please read and understand the details of the “Employee Referral Program (ERP)” on the AskGS and you have made a compliant referral.

Required Skills:Preferred Skills:

Budgeting, Clinical Trial Designs, Clinical Trials, Compliance Management, Consulting, Contract Management, Execution Focus, Fact-Based Decision Making, Give Feedback, Industry Analysis, Laboratory Operations, Organizing, Process Improvements, Project Integration Management, Research and Development, Research Ethics, Technical Credibility