Assistant Director, Regulatory Affairs

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Reporting directly to the Yale Cancer Center (YCC) Clinical Trials Office (CTO) Director of Operations, the Assistant Director, Regulatory Affairs acts as sole leader of the Clinical Trials Office regulatory division, overseeing the central regulatory teams Regulatory Managers, Regulatory Affairs Specialists, and Regulatory Research Assistants. This position creates functional strategies and specific objectives for the regulatory team, developing workflows, implementing policies and procedures, monitoring compliance, educating colleagues, and assessing performance of employees to support the functional infrastructure.

The Assistant Director works in partnership with other Assistant Directors within the CTO to ensure compliance, coordination, and cohesive communication across all aspects of the CTO

• 1. Solely directs and oversees the centralized regulatory team’s function for the Yale Cancer Center, Clinical Trials Office disease team portfolio.
• 2. Provides overall management, structure and regulatory leadership for the development and implementation of all regulatory processes within the CTO Regulatory Office.
• 3. Creates functional strategies and specific objectives for the assigned disease team portfolios and develops workflows, policies, and procedures to support the functional infrastructure.
• 4. Provides strategic input to leadership related to short and long-term planning for the Cancer Center Clinical Trials Office.
• 5. Develops, implements, and evaluates effectiveness of short and long-term objectives for assigned portfolios related to productivity, compliance, communication, and patient satisfaction.
• 6. Designs and implements process improvement initiatives to meet goals and objectives.
• 7. Manages and directs the ongoing and day to day operations of the assigned disease team portfolio staff, consisting of Senior Regulatory Project Managers, Regulatory Project Managers, Regulatory Managers, Regulatory Assistants, and Research Assistants in Regulatory Affairs.
• 8. Establishes priorities with appropriate timelines for to ensure efficient and effective operations.
• 9. Deploys resources among teams in collaboration with faculty DART leaders.
• 10. Ensures the competency of staff across each disease team through effective onboarding, and ongoing training programs, coaching and mentoring.
• 11. Ensures full compliance of clinical research and regulatory operations within the span of authority of the position, making informed decisions on established and proposed regulations, and communicating to senior management team as well as Yale Cancer Center faculty.
• 12. Prepares responses to FDA, industry sponsor, and cooperative group audit findings.
• 13. Designs, implements, and monitors corrective action plans.
• 14. Drives operational changes to achieve best in class operations throughout the organization based on the findings of internal or external auditors, confirming full compliance of requirements of Clinical Trials Reporting Program (CTRP).
• 15. Manages and directs the regulatory compliance functions inherent to oncology clinical research of assigned disease team portfolios, including effectively and efficiently collaborating with external sponsors on requisite platforms and portals.
• 16. Oversees the activities necessary to ensure effective and timely activation of clinical trials within disease team portfolios from stage of protocol…