Position Focus:

Acts as sole leader of the Clinical Trials Office regulatory division, overseeing the central regulatory teams including Senior Regulatory Project Managers, Regulatory Project Managers, Regulatory Managers, Regulatory Assistants, Research Assistants, and CTRP functions for the Yale Cancer Center.

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.

Works in partnership with other Assistant Directors within the Clinical Trials Office (CTO) to ensure compliance, coordination, and cohesive communication across all aspects of the CTO

Essential Duties

1. 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.

Required Skill/Ability 1:

Ability to clearly communicate and understand written information.

Required Skill/Ability 2:

Ability to analyze ideas, use logic, and recognize the nature of issues to develop creative problem-solving opportunities.

Required Skill/Ability 3:

Ability to motivate, develop, and assess learning capacity of direct reports.

Preferred Education, Experience and Skills:

A BA/BS degree or equivalent with minimum of 5 years direct regulatory supervisory experience, plus 7 years of regulatory experience. Advanced knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations.

Preferred Licenses or Certifications:

ACRP/SoCRA (or equivalent) certification preferred. Knowledge of National Cancer Institute Cancer Center Support Grant (NCI CCSG P30) preferred.

Weekend Hours Required?

Occasional

Evening Hours Required?

Occasional

Drug Screen

No

Health Screening

No

Background Check Requirements

All 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. Please visit www.yale.edu/hronline/careers/screening/faqs.html for additional information on the background check requirements and process.

Posting Disclaimer

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 particular position. Employees will be assigned specific job-related duties through their hiring departments.

Affirmative Action Statement:

Yale University considers applicants for employment without regard to, and does not discriminate on the basis of, an individual’s sex, race, color, religion, age, disability, status as a veteran, or national or ethnic origin; nor does Yale discriminate on the basis of sexual orientation or gender identity or expression. Title IX of the Education Amendments of 1972 protects people from sex discrimination in educational programs and activities at institutions that receive federal financial assistance. Questions regarding Title IX may be referred to the University’s Title IX Coordinator, at TitleIX@yale.edu, or to the U.S. Department of Education, Office for Civil Rights, 8th Floor, Five Post Office Square, Boston MA 02109-3921. Telephone: 617.289.0111, Fax: 617.289.0150, TDD: 800.877.8339, or Email: ocr.boston@ed.gov.

Note

Yale University is a tobacco-free campus