Assistant Director, Regulatory Affairs

Working at Yale means contributing to a better tomorrow. Whether you are a current resident of our New Haven-based community, eligible for opportunities through the New Haven Hiring Initiative, or a newcomer, interested in exploring all that Yale has to offer, your talents and contributions are welcome. Discover your opportunities at Yale!OverviewReporting 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 CTOWorks to direct, implement, educate, and communicate all aspects of the YCC Clinical Trials Office regulatory function, using accepted industry and institutional standards and policies in clinical research, in partnership with all relevant constituents.Principal Responsibilities1. 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 concept through obtaining open to accrual status.17. Utilizes data to effectively monitor the process for protocol activation. Drives reduction of activation timelines in regulatory processes.18. Ensures compliance with University and Federal regulations, GCP and HIPAA as they apply to Regulatory Office.19. Manages and coordinates training sessions for assigned departments/groups when new policies or practices are adopted.20. Assesses and makes recommendations regarding staff development and staffing levels, including job posting requirements, salary guidelines and labor agreement interpretations for exempt and non-exempt staff.21. Interfaces with other CTO Assistant Directors to ensure regulatory communication, training, support, and information is disseminated throughout the CTO, supporting compliance.22. Participates in ongoing educational efforts across the CTO to ensure regulatory standards and knowledge are shared with CTO staff.23. Participates in process initiatives and other activities held internally and externally involving the CTO which are designed to promote positive change, enhancement, and improvement of regulatory activitiesRequired Skills and Abilities1. Expert knowledge and application of applicable federal regulations governing human subjects research, including FDA regulations, International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) Guidelines, Office for Human Research Protections (OHRP) regulations, HIPAA Privacy Rule, and institutional policies governing clinical research.2. Demonstrated ability to supervise, mentor, coach, and develop regulatory staff; delegate responsibilities appropriately; manage performance; and foster a collaborative, accountable, and high-performing team environment. Ability to effectively plan, prioritize, allocate, and optimize human, operational, and financial resources to support a complex clinical research regulatory program while ensuring compliance, quality, and timely achievement of organizational objectives.3. Advanced communication, leadership and team building skills: evidence of this should include, effective problem solving, conflict resolution, motivating others as individuals and as groups, and planning, organizing, and directing the activities of others.4. Comprehensive decision-making skills with ability to make independent and timely decisions; communicates, influences and escalates issues, and serves as final authority, as appropriate. Capable of leading multiple projects within multidisciplinary environments at the same time.Preferred Skills and AbilitiesMaster’s Degree. Knowledge of National Cancer Institute Cancer Center Support Grant (NCI CCSG P30) preferred.Physical RequirementsAble to assist with transport of regulatory binders and files to audit and other monitoring locations as needed.Principal Responsibilities1. Directs, monitors, and assesses needs and directs the application of resources of an administrative University office dealing with one or more major functional areas. 2. Directs and implements solutions to problems that are routine to complex in nature and that affect multiple functional areas of responsibility. 3. Plans and/or participates in planning University activities on a long-term basis to comply with University goals and objectives. 4. Establishes and implements consistent university-wide policies in multiple functional areas of responsibility. 5. Ensures that University office policies and procedures are in compliance with federal, state, and local laws and ordinances. 6. Develops and monitors goals and objectives for managerial and professional staff in compliance with University strategies. 7. Directs a staff of exempt and non-exempt employees. 8. May perform other duties as assigned. Required Education and Experience Bachelor’s Degree in related field and eight years of experience or an equivalent combination of education and related experience.Job Posting Date08/17/2026Job CategoryManagerBargaining UnitNONCompensation GradeAdministration & OperationsCompensation Grade ProfileLeader (27)Salary Range$105,000.00 - $174,000.00Time TypeFull timeDuration TypeStaffWork ModelRemoteBackground Check RequirementsAll candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. All offers are contingent upon the successful completion of the background check. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website.Health RequirementsCertain positions have associated health requirements based on specific job responsibilities. These may include vaccinations, tests, or examinations, as required by law, regulation, or university policy.Posting DisclaimerSalary offers are determined by a candidate’s qualifications, experience, skills, and education in relation to the position requirements, along with the role’s grade profile and current internal and external market conditions.The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the position. Employees will be assigned specific job-related duties through their hiring department.The University is committed to basing judgments concerning the admission, education, and employment of individuals upon their qualifications and abilities and seeks to attract to its faculty, staff, and student body qualified persons from a broad range of backgrounds and perspectives. In accordance with this policy and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual’s sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran.Inquiries concerning Yale's Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA).NoteYale University is a tobacco-free campus.