Director, Global Clinical Operations – Compliance
BeOne Medicines
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $173,000 - $233,000 per year
Job Level
Lead
Tech Stack
Google Cloud Platform
About the role
- The Director, Global Clinical Operations, Compliance builds, collaborates and manages key relations to better support and understand the compliance-related needs of the business and drive the compliance activities within Global Clinical Operations.
- Provides quality guidance, direction and expertise to GCO stakeholders for the compliant conduct of study programs; designs, implements and monitors measures to reduce compliance risks and enhance successful clinical trial conduct.
- Develops partnerships with key enterprise business partners and stakeholders to advance compliance solutions, embed preventive compliance and enable transparency, escalation, and resolution of quality and compliance matters.
- Works collaboratively with global and regional study teams to ensure that proper root cause assessments, corrective and preventive actions for quality issues, site non-compliance, audit and inspection findings are in place, and that lessons learnt are disseminated and actioned upon within the broader GCO organization.
- Identifies and escalates significant compliance issues within GCO and to relevant leadership, including assessment of serious breaches.
- Contributes to the design and implementation of risk identification and management strategies for clinical studies and other regulated drug development activities.
Requirements
- Bachelor’s degree in Life Sciences, Medicine, Quality Management, or related field and at least 10 years of relevant experience; or Master’s degree in Life Sciences, Medicine, Quality Management, or related field and at least 7 years of relevant experience.
- Relevant experience can be in drug development, clinical operations, clinical quality assurance, medical affairs, clinical regulatory compliance or a related field.
- Knowledgeable in stakeholder management and influencing change.
- Must demonstrate knowledge of and strong aptitude to learn about the evolving legal and regulatory environment, ICH GCP, applicable laws, regulations, and industry standards as it relates to a global pharmaceutical organization.
- Must understand corporate (local and global) and organization (local and global) policies, procedures and guidelines.
Benefits
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical operationscompliance managementrisk identificationquality assuranceclinical regulatory compliancestakeholder managementroot cause assessmentcorrective actionspreventive actionsdrug development
Soft skills
collaborationcommunicationinfluencing changeproblem-solvingleadershiprelationship managementtransparencyescalationresolutionorganizational skills