Assistant Director, Quality and Education

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 research oversight activities (e.g., monitoring, internal and external reviews, audits, and inspections); systematic reviews that evaluate researcher and study team compliance with IRB approved protocols and applicable laws, regulations, and standards; and the oversight, investigation, and escalation of compliance issues and complaints.
3. Leads, manages, and advises on quality matters (quality control, quality assurance, and quality improvement) as assigned. This includes leading, managing, and advising on the following: YCC quality; post-IRB approval monitoring of research studies and other quality improvement activities; reporting and tracking of monitoring findings and reports requested from sponsors, federal agencies, and other oversight bodies; and ensuring that periodic audits of the internal and external IRBs are conducted to ensure compliance.
4. Leads, manages, and advises on operational matters and ensures operational efficiency and compliance with laws, regulations, and standards related to the conduct of human research. This includes leading, managing, and advising on the following: departmental and cross-departmental initiatives, projects, and requests for assistance by the University community; delivery of day-to-day service levels, customer experience, and quality measures; change management within the YCC; collaborations with other business units; strategic objectives set forth by the YCC and University; operational effectiveness and strategies to ensure quality and efficiency; operational opportunities, risk management, and continuous quality improvement; and verifying that institutional requirements have been satisfied.
5. Leads, manages, and advises on relationships external to the YCC and University as assigned. This includes: facilitating discussions with research investigators, program directors and high-ranking officials from external institutions or organizations who are interested in pursuing a collaborative research affiliate relationship with Yale University; collaborating with ancillary committees, departments, and organizations external to Yale regarding human research matters; and managing reliance and other agreements.
6. Leads, manages, and advises on matters related to YCC accounts receivable, billing, and financial forecasting and reporting as assigned.
7. Leads, manages, and advises on medical and scientific matters related to human research protection program matters as assigned.
8. Other Duties as assigned.

Required Education and Experience

Bachelor’s degree; 7 years of relevant experience in research administration or human subject protection with 5 years prior monitoring experience in industry or at a large academic institution, hospital/medical center, or non-profit organization/foundation; or an equivalent combination of education and experience.