Associate Director, Clinical Research Program - Breast Oncology

The Associate Director, Clinical Research Program will oversee all Breast Oncology clinical trials and translational research operations, regulatory and compliance within the assigned program(s).

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.

• Oversee and organize recurring meetings for translational and clinical trials research, disease specific projects, portfolio review, and budget
• Oversee in collaboration with leadership, institutional clinical research priorities, goals and key performance indicators
• Able to act fully autonomously, to execute high level decisions independently with little or no supervision and to consistently formulate solutions to complex situations.
• Oversee Clinical Research Managers, including Translational Program Manager, Assistant Research Manager(s) and indirect supervision of Regulatory Operations Manager and support staff. Support Research Manager(s) in recruiting and hiring staff
• Support portfolio, low accrual trial monitoring system, and Workload/Resource Utilization Tool development incorporating feedback from investigators and Clinical Trials management platforms, tracker and roadmaps.
• Oversee investigator-initiated and grant funded clinical trials including development of protocols/budgets, support the contract process, and coordinate correlative sample processing
• Lead process improvement projects to increase accrual and study approval/activation timelines
• Lead process improvement projects to increase consent and collection rates
• Support for Clinical Research Manager, Regulatory Operations Manager, CTO Project Manager(s) in operationalizing the Portfolio Workload Tool with direct supervision from the CTO
• Support Clinical Research Manager, Regulatory Operations Manager, and Translational Research Manager in recruiting and hiring new Clinical Research Coordinators, Regulatory Coordinators, and Research Data Specialists
• Liaise with Clinical Research finances including federal, philanthropic, foundation, and industry funding sources
• Facilitate communication with the Research Administrators, Grants & Contracts, CTBO, and other internal groups
• Engage in strategic financial planning in collaboration with department leaders
• Mentor staff program to promote growth within the research program
• Monitor clinical research staff allocations and staff satisfaction
• Support staff responsible for larger initiatives include translational coordinators and project/program managers.

MINIMUM JOB QUALIFICATIONS:

• Bachelor's degree in a field relevant to research compliance required, Master’s degree or higher preferred.
• 10 years of increasing expertise and responsibility in regulatory and clinical trials required; 5 years with advanced degree.
• Previous experience in the conduct of clinical trials and research operations required.
• Experience in US drug and biologics regulations and an excellent understanding of clinical trial processes and research operations required.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• Knowledge of ICH GCP practices and clinical trial designs.
• Full functional knowledge of FDA regulations relevant to the development and approval of new therapeutic agents, biologics, vaccines, and medical devices.
• Comprehensive knowledge of regulatory requirements (regulations, directives, and guidance/guidelines) pertaining to the development and registration of drug products in US.

SUPERVISORY RESPONSIBILITIES:

Directly supervises Clinical Research Manager, Translational Program Manager; indirectly manages and/or supports other translational and clinical research staff (e.g., Assistant Clinical Research Managers, Research Project Managers, Research Program Managers, Research Data Specialists, Clinical Research and Regulatory Operations Managers, Clinical Research Coordinators, etc.).