The Director GCO, Country Head Israel is accountable for strategic and operational management of clinical research and development activities in mid to large-size country. This leads to successful country execution of all phases of clinical trials, 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 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) overall.
1. Define and execute long term strategy in alignment with 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, 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).
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.
* Bachelor's degree or equivalent required, preferably in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy). Advanced degree in a scientific discipline and/or Master’s degree is preferred.
* Minimum of 10 years of clinical research experience acquired in pharmaceutical industry, CRO or investigational site.
* Minimum 5 years of experience in managing large teams (at least 50 employees), accountable for resource management, development of the teams, budget management and delivery of clinical trials committed in the country.
* Excellent communication and leadership skills. Proven ability to foster team productivity and cohesiveness.
* Ability to manage complexity under pressure. Proven track record of people and project management. Strong in hiring, training, developing and evaluation of leaders and people managers.
* Strong decision-making and financial management skills. Flexibility to work in a rapidly changing environment with the appropriate sense of urgency.
* Experience in transforming organizations in response to business needs.
* 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 synthesize and 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.
Operates with limited supervision.
* Proficiency in English.
* Computer literacy.
* Strong interpersonal and negotiating skills. Excellent organizational skills and ability to collaborate and handle multiple priorities within a matrix environment.
* Perform activities in a timely and accurate manner