Beijing, CHN
9 days ago
Senior Director, Head of GCO China
Position Summary: A Sr Director Country Head is accountable for strategic and operational management of clinical research and development activities in a large-size country (as determined by GCO Leadership). The Sr Director Country Head is accountable for the successful 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 in the country. The Sr Director Country Head 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 (FM)/Clinical Research Managers (CRM) and other GCO staff, as required. Ensures alignment of local goals with organizational objectives. Drives innovative solutions and process improvements for the cluster/region or GCO/Global Development (GD) overall. The Sr Director contributes to the development and execution of strategies in support of overall leadership team and broad GCO functional objectives and may lead capability and process improvement initiatives with scope and impact beyond role’s primary geographical responsibilities Principal Responsibilities: 1. Define and execute long term strategy in alignment with GD and JJIM R&D strategies to position the country for success. Contribute to development of global and regional approaches and implementation plans. Enable team to deliver plans and actions associated with the strategy. 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. Accountable for ensuring all operational objectives are met in conformance to ICH-GCP, relevant SOPs, other procedural documents, and local regulations (including safety reporting). 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. Strategic input and oversight of approaches to evaluate and develop cost efficiencies in country and support broader functional opportunities. Enable implementation of budget improvement initiatives through country team. 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. Active membership of, or strong partner for, regional and or global GCO leadership teams. 9. Contributes to the development and execution of strategies in support of overall leadership team and broad GCO functional objectives. May lead capability and process improvement initiatives with scope and impact beyond role’s primary geographical responsibilities. 10. Develop country capabilities for effective study placement. 11. Accountable for the selection of sites to deliver on country commitments and strategic goals. 12. Accountable for ensuring the country compliance with quality and operational metrics. Lead regular metrics review and necessary follow-up actions. 13. Contribute to local regional and global strategy development and evaluation of new processes and standards to improve clinical trial management as well as lead their rollout in the country and globally. GCO lead on global improvement initiatives. 14. Foster a culture of continuous improvement and innovation within the local GCO team. 15. Model Credo based culture within the local GCO team. 16. Contribute to shaping environment for clinical trials in the country. Ensure strategy and team assignments develop plans and strategy for team engagement with local investigational sites, regulatory bodies and key stakeholders within the country. May participate or take lead roles in national pharmaceutical association forums. Responsible for shaping the external environment strategy and influencing policies and practices in clinical trials. 17. Responsible for line management and development of GCO staff up to Director level ensuring development plans are in place and performance goals met. Directs and delegates country-level talent acquisition and development strategies with input on global functional talent strategy. Plays a role in shaping the organizational structure to meet future challenges and business objectives. 18. Evaluate and forecast overall resource needs for the country. 19. Responsible for the deployment of the One Delivery Model in the country. 20. Accountable for the acquisition of new talents and development of human resources. 21. Mentor and support country heads to enable development and performance in other countries as requested. 22. Lead organizational changes and effectively communicate on priority shifts as required in country and globally. 23. Review and approve expenses in compliance with the company policies. 24. Strongly demonstrate leadership behaviors in alignment with J&J Leadership Imperatives. 25. Foster an environment that encourages sharing of ideas, information, and best practices (internal and external to the organization). 26. Provide coaching or mentorship as needed. This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned. **Qualifications** Education and Experience Requirements: + 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 12 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. 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 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. + 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.
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