Assistant Director, Regulatory Affairs

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.

Principal Responsibilities

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 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 activities

Required Skills and Abilities

1. 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 Abilities

Master's Degree. Knowledge of National Cancer Institute Cancer Center Support Grant (NCI CCSG P30) preferred.

Physical Requirements

Able to assist with transport of regulatory binders and files to audit and other monitoring locations as needed.