BeOne Medicines I GmbH is hiring a Regional Clinical Compliance Director/Senior Director

BeOne Medicines I GmbH is hiring a Regional Clinical Compliance Director/Senior Director to implement our Global Clinical Compliance and Inspection Management strategy. In this role, you will provide crucial compliance oversight and quality support to ensure Good Clinical Practice (GCP) adherence and inspection readiness across our clinical activities.

What You'll Do

• Implement Global Clinical Compliance and Inspection Management strategy across clinical activities at global, regional, country, site, and/or study levels.
• Provide compliance oversight and quality support to Global Clinical Operations (GCO) study teams for assigned studies.
• Ensure appropriate GCO study conduct, inspection readiness, and overall compliance to applicable regulatory requirements is systematically maintained.
• Seek opportunities to implement best practices, share lessons learned, and drive improvements within the Clinical Compliance and Clinical Operations teams.
• Support timely identification, escalation, and tracking of non-compliance issues, quality events, potential misconduct, or potential Serious Breaches.
• Support inspection readiness, preparation, hosting, response management, and lesson-learned development.
• Provide team leadership, guidance, oversight, and GCP expertise to Regional Clinical Compliance stakeholders.
• Foster collaborative relationships with key stakeholders to enable timely problem identification and ensure proper root cause assessments and CAPAs.
• Support drafting responses and CAPA plans for internal/external audits and inspections.
• Provide GCP compliance guidance and support to Clinical Study Teams and other GCO stakeholders across a portfolio of studies.
• Ensure development and implementation of GCP inspection readiness programs at study, country, regional, and/or global levels.
• Approve On-Site Compliance Visit (SCV) and Remote Compliance Review scheduling and preparation for assigned studies.
• Peer review Compliance Assessment reports (e.g., SCV, Remote Compliance Review).
• Lead RCC management in monitoring Key Compliance Indicators (KCI) and developing metrics.
• Conduct trend analysis to identify compliance risks and opportunities for optimization.
• Establish preventive action-related initiatives to mitigate risks proactively.
• Drive the development and implementation of internal GCP compliance process improvement strategies, tools, and initiatives.
• Lead development of GCP Compliance and inspection readiness management programs and associated training material.
• Provide expertise and guidance on initiatives involving processes and systems for clinical trials to ensure ICH GCP and local regulation compliance.
• Provide feedback on investigator site performance for future study feasibility.
• Stay abreast of new and revised government, industry, and company regulations, trends, and interpretations.
• Oversee the work of direct/indirect reports to ensure on-time, on-target, and within-budget results.
• Conduct regular 1:1 meetings, mid-year and year-end performance appraisals, and provide constructive feedback for direct reports.
• Engage in career development planning for direct reports.
• Mentor Clinical Compliance team members by delegating responsibilities and overseeing assigned tasks.
• Provide constructive feedback on Clinical Operations team members to their line managers.

What We're Looking For

• Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical, or healthcare discipline.
• Minimum of 14 years of progressive experience in clinical operations roles.
• Excellent working knowledge of ICH/GCP, regional regulations, SOPs, and Clinical Operations Work Instructions.
• Demonstrates a high level of clinical operations knowledge.
• Strong analytical and managerial skills.
• Excellent English written and verbal communication and interpersonal skills.
• Excellent organizational, presentation, and training skills, with an ability to prioritize and multi-task.
• Ability to work independently in a multi-cultural setting and effectively handle multiple priorities in a fast-paced environment.
• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).
• Up to 10-15% travel.

Nice to Have

• Minimum 14 years’ experience in a GCP compliance or equivalent role (i.e., quality).
• Experience in oncology global trials.

Technical Stack

• MSOffice: Outlook, Word, Excel, PowerPoint

Team & Environment

You will provide team leadership to Regional Clinical Compliance stakeholders and oversee direct and indirect reports.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.