HireDiversity

Beijing, CN

Head of GCO, China Senior Director, GCO China-00000833

Description

OVERALL PURPOSE OF THE JOB:

To lead the China GCO organization in the execution of Clinical Trials at the highest level of Quality and Ethics.

To represent the China GCO organization to both the Asia Pacific GCO organization and the China R&D organization.

To ensure effective communications between the country teams and regional and global groups.

To drive the strategy and guide the implementation of the activities outlined by both the China R&D organization and the functional GCO organization.

Todevelop the GCO China team to a high performing organization.

CORE ACTIVITIES:

- Responsible for the execution of clinical trials by the employees of the GCO China team according to protocol, international Guidelines for Good Clinical Practice, international and national SOPs and local procedures and regulations
- Set Goals & Objectives for the GCO China organization in collaboration with the VP GCO AP (Asia Pacific) and ensure objectives are achieved as to timeline and budget
- Ensure objectives are achieved (flawless execution of clinical trials within the set timelines and budget).
- Manage, evaluate and develop employees within the GCO organization
- Ensure correct application of the worldwide harmonized Good Clinical Practice principles for the conduct of clinical trials as well as correct implementation of the international and national Johnson & Johnson Pharmaceutical Research and Development (JJPRD) and/or GCO clinical trial SOPs
- Identification and management of high quality investigational sites and of local external resources (CRO's, scientific advisors, etc.)
- Ensure clinical trial projects are sufficiently resourced, done effectively and results are communicated in a timely fashion to the teams
- Actively manage clinical trials portfolio for GCO team and continuously strive for optimal access for central teams to available pool of investigators and trial candidates
- Ensure country specific requirements are properly communicated to the central teams
- Inform the teams about resource availability and possible cost implications
- Track country performance
- Pro-active identification of issues and problems, and ensure timely communication and issue escalation to teams to allow appropriate solutions to be developed and implemented
- Manage continuous process improvement

Member of the China R&D Leadership Team and the Asia Pacific GCO Leadership Team
- As a senior member of both the China R&D Leadership team and the Regional GCO Leadership Team work to promote the GCO function and team to the broader organization.
- Ensure effective and regular communications between Country and Regional teams.

Contribute to shaping the GCO Strategy within Asia Pacific

Qualifications


CORE COMPETENCIES REQUIRED FOR THIS ROLE:
- Strong knowledge of ICH-GCP (International Conference on Harmonization - Good Clinical Practice), relevant local regulations related to clinical research
- Proven track record of People development
- Ability to lead through ambiguity
- Internal and external partnering, ability to build relationships at all levels across the business and externally
- Innovation and transformation, ability to improve the business by innovative initiatives
- Big Picture Orientation and Strategic Thinking
- Operational excellence, ability to develop and align priorities, manage time, utilize resources and ensure quality to effectively achieve goals and objectives
- Demonstrates a strategic mindset
- A track record of driving Quality & Compliance performance
- Experience in leading large teams through significant change
- Strong can do attitude and result orientation

Fluency in Mandarin and English is required;

OTHER FEATURES OF THE JOB:
- Travel requirement of approximately 30% within China and Asia Pacific

Primary Location:Asia Pacific-China-Beijing-Beijing
Organization: Xian-Janssen Pharmaceutical Ltd. (7043)
Travel:Yes, 50% of the time
Job Function: Clinical Trial Administration