Assistant Director, Quality and Education

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Overview
Yale Cancer Center Clinical Trials Office (YCC CTO) is seeking a dynamic Assistant Director, Quality and Education, to provide technology-forward leadership and programmatic support for the Quality and Education function within the CTO. Reporting to the Quality and Education Director, this role will translate quality and education priorities into scalable, technology-enabled programs, including system-supported workflows, standardized documentation, role-based training, and fit-for-purpose reporting. The Assistant Director will lead complex, cross-functional initiatives to implement, optimize, and sustain integrated systems and data solutions that strengthen oversight, compliance, and continuous improvement.  This position will also lead and be responsible for governance structures—such as intake, prioritization, change control, and validation/readiness practices—to ensure technology changes are controlled, documented, and aligned with quality standards. The role provides consistent leadership, coordination, and continuity across Quality and Education initiatives, ensuring programs and tools remain aligned with evolving needs, priorities, and regulatory expectations.

Required Skills and Abilities

1. Strong working knowledge of Good Clinical Practice and demonstrated experience interpreting federal, state, local, and sponsor regulations to drive consistent, high-quality, compliant research practices.

2. Proven ability to lead education and ongoing professional development for clinical research staff by translating CFR, GCP/ICH, protocol requirements, and sponsor/institutional policies into scalable, role-based training programs. Experience converting complex oncology trial requirements into standardized documentation, job aids, and technology-enabled learning resources that support high-performing research teams.

3. Demonstrated ability to strengthen and lead oversight, compliance, and continuous improvement through quality systems, system-supported workflows, and fit-for-purpose reporting. Using data and trend analysis to monitor performance, identify gaps, and implement corrective and preventive actions that strengthen oversight, compliance, and continuous improvement. Expert project management skills leading technology-forward quality initiatives end-to-end (requirements gathering, stakeholder alignment, implementation planning, risk/issue management, testing/validation readiness, training, go-live, and stabilization).

4. Proven experience leading complex, cross-functional, technology-enabled projects to implement, optimize, and sustain workflows and data solutions that improve consistency, traceability, and operational performance. Ability to build and maintain governance practices—intake, prioritization, change control, documentation control, and validation/readiness—to ensure technology changes are controlled, auditable, and aligned with quality standards.

5. Demonstrated leadership, communication, and team-building skills, including effective problem-solving, conflict resolution, resource coordination, and the ability to plan, organize, and direct work across cross-functional stakeholders. Proven ability to lead and motivate teams (including geographically dispersed groups), influence without authority, and drive adoption of new tools and processes through structured change management, clear communication, and practical training. Outstanding verbal/written communication, collaboration, negotiation, and influencing skills to keep Quality and Education programs aligned with evolving needs and regulatory expectations.

Preferred Education and Experience:

1. Experience in oncology clinical research.

2. Certification through SOCRA, ACRP or equivalent

Principal Responsibilities

1. Leads, manages, and advises on regulatory matters as assigned. This includes: serving as an expert resource regarding applicable laws, regulations, and standards governing human subjects research conducted in the United States and other countries; providing advice and ensuring the efficient review, identification, and resolution of regulatory issues with a focus on customer service and compliance; and delivering relevant training.  
2. Leads, manages, and advises on compliance matters as assigned.  This includes leading, managing, and advising on the following: human re