Regional Clinical Compliance Director / Senior Director

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description :

The Regional Clinical Compliance (RCC) Director / Senior Director is responsible for implementing Global Clinical Compliance and Inspection Management strategy across BeOne Medicines Clinical activities at global, regional, country, site and / or study levels as applicable.

In summary :

• Provides compliance oversight as well as quality support to BeOne GCO study teams, for their assigned studies and ensures that appropriate GCO study conduct, inspection readiness, and overall compliance to applicable regulatory requirements is systematically maintained.
• Seeks opportunities to implement best practices, share lessons learned, lead and drive improvements to optimize effectiveness and efficiency within the Global and Regional Clinical Compliance team, as well as within the Global and Regional Clinical Operations team.
• Supports timely identification of non-compliance issues and quality events, ensure appropriate escalation of those issues and events as well as potential misconduct or potential Serious Breach to relevant stakeholders.
• Tracks and trends non-compliance issues, quality events, and any other relevant observations identified during Site Compliance Visits, to help identify issues and risks across BeOne study programs and processes. The job holder supports Global and Regional Clinical Compliance in the development of subsequent GCP readiness activities and programs.
• Adheres to ICH / GCP, local regulations, applicable BeOne SOPs and contributes to the development and / or review of Clinical Operations Work Instructions and SOPs.
• Demonstrates significant clinical study experience and understanding of investigational site setup, trial management, trial conduct at study & site level, as well as clinical operations processes.
• Demonstrates BeOne clinical operations knowledge, organizational skills, project management and leadership competencies.
• Supports inspection readiness, preparation, hosting, response management and further lesson-learned development, as applicable.

Essential Functions of the Regional Clinical Compliance Director / Senior Director :

Core Competencies, Knowledge and Skill Requirements :

Communication & Interpersonal Skills :

Supervisory Responsibilities :

Education Required :

Computer Skills : PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)

Travel : up to 10-15% travel

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.