Senior Director, Clinical Trials Office

Overview

The Senior Director, Clinical Trials Office (CTO) supports department teams and functions across Dana-Farber Cancer Institute’s (DFCI) Longwood Medical Area campus essential for clinical research operations. Teams and functions include clinically facing clinical research management; regulatory affairs; training and education; and project management and monitoring programs. The Senior Director CTO works cross functionally across DFCI departments and Disease Centers to coordinate CTO activities and represents DFCI clinical research interests across various committees and working groups advancing shared programmatic activity across the NCI-designated cancer consortium.

Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

Responsibilities

• Clinical Research Operations. Directs team leaders overseeing clinical research management including on-site deployment of clinical research coordinator teams across DFCI Disease Centers
• Regulatory Affairs. Supports regulatory operations and teams responsible for monitoring and audit of industry-sponsored and investigator-initiated clinical trials. Partners with the Office of Human Subjects Research ensuring compliance with all institutional policies and procedures. Interprets State and Federal regulations and mitigates risk across the DFCI research enterprise. Partners with DFCI Clinical Research Directors on corrective action planning, follow-through and reporting.
• Training and Education. Develops training and education resources for implementation across core CTO functions targeting non-faculty members of the study team: clinical research coordinators, regulatory operations, and research data management.
• Policies and Procedures. Sets and communicates institutional policy and procedural standards to CTO teams and serves as a subject matter expert across DFCI departments related to policy creation impacting clinical research operations.
• Study Start-up. Coordinates clinical research operational activities across DFCI departments to expedite study start-up and activation, amendments, treatment and follow-up, and close-out activities with a focus on efficient execution of all activities within the clinical trials lifecycle.
• Data and Financial Management. Ensures timely management and accurate reporting of clinical data into institutional and sponsors’ electronic data capture systems. Facilitates teams to consistently meet institutional requirements for study- and protocol-related financial reporting.
• Supervises staff. Hires and develops team members with the capabilities to achieve organizational goals. Defines and communicates clear expectations, provides regular constructive feedback, and evaluates performance against objectives. Oversees team’s compliance with organizational policies and procedures. Monitors work for efficiency, effectiveness, and quality. Mentors and coaches staff, facilitating training opportunities and supporting career growth. Works with senior management and Human Resources to address performance issues, as appropriate. Promotes and fosters a healthy and productive work environment within the team and with groups across the Institute.

SUPERVISORY RESPONSIBILITIES:

Supervises CTO Associate Directors and Project Managers and Clinical Research Managers.

PATIENT CONTACT:

Minimal – related to study coordination (CRC management) activities.

Qualifications

At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.

MINIMUM JOB QUALIFICATIONS:

• Bachelor’s degree required; advanced degree preferred
• 10 years of experience in clinical research operations, compliance and regulatory affairs required
• 5 years of experience managing staff responsible for clinical trials operations
• 5 years of experience leading clinical trial audit and monitoring activities
• 5 years of experience using, designing, and/or deploying clinical trials management systems (CTMS) and protocol regulatory management systems (PRMS)

Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.