Director, Global Clinical Operations – Compliance

Job Description: • 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 Apply tot his job Apply To this Job