VP, Clinical Research Management
Dana-Farber Cancer Institute
Full Time Remote: 2-3 days
Dana-Farber Cancer Institute
The mission of Dana-Farber Cancer Institute is to provide expert, compassionate care to children and adults with cancer while advancing the understanding, diagnosis, treatment, cure, and prevention of cancer and related diseases. As an affiliate of Harvard Medical School and a Comprehensive Cancer Center designated by the National Cancer Institute, the Institute also provides training for new generations of physicians and scientists, designs programs that promote public health particularly among high-risk and underserved populations, and disseminates innovative patient therapies and scientific discoveries to our target community across the United States and throughout the world.
The Dana-Farber Cancer Institute (DFCI) is a world leader in basic and clinical research, training, and application of advanced diagnostic and treatment methods relating to cancer. The National Cancer Institute named Dana-Farber as one of the country's seven original comprehensive cancer centers in 1973. Today, Dana-Farber is the administrative home for the Dana-Farber/Harvard Cancer Center, (DF/HCC, described below), one of more than forty NCI designated comprehensive cancer centers.
Dana-Farber/Harvard Cancer Center
Founded in 1998, the DF/HCC unites the major clinical, population, and basic cancer research efforts of the Dana-Farber Cancer Institute, the Harvard Medical School and Harvard T.H. Chan School of Public Health, Beth Israel Deaconess Medical Center, the Brigham and Women's Hospital, Boston Children's Hospital, and Massachusetts General Hospital.
DF/HCC is the largest of the Comprehensive Cancer Centers formally designated by the National Cancer Institute. The DF/HCC links more than 1100 cancer scientists into an organizational structure designed to foster the interaction and collaboration that will lead to new, more effective approaches cancer prevention, diagnosis, and treatment. Research in the Center is carried out in 17 disease-and-discipline based programs that cross both institutional and scientific boundaries. The Center also provides infrastructure for more than 16 core facilities that provide shared resources to Center members, facilitating scientific progress. Together, these programs and core facilities are fundamental to the multi-modality approach to clinical, as well as non-clinical, research and care. The Dana-Farber/Harvard Cancer Center supports the infrastructure for this unified expanded system of cancer research clinical trials.
DFCI has one of the largest cancer clinical trials programs in the country, with nearly 700 adult and pediatric therapeutic trials actively accruing patients. Importantly, more than one-quarter of these studies are investigator-initiated and one-third are Phase I or I/II, demonstrating their commitment to translate basic research findings to the clinic through proof-of-principle and early phase studies.
DF/HCC is administratively housed at DFCI supports the infrastructure for a unified expanded system of clinical trials, and the DFCI IRB is the IRB of record for the DF/HCC clinical trials system. Currently, the DF/HCC has approximately 1,000 clinical trials open to enrollment across the consortium. The DF/HCC clinical trials enterprise enrolls ~ 4,000 subjects in interventional treatment trials per year.
Reporting to the Senior Vice President for Research Administration, the Vice President, Clinical Research Management is a senior administrator within the Dana-Farber Cancer Institute. This senior executive position is responsible for the clinical research operations of the institute including, but not limited to oversight of DFCI’s Clinical Trials Office which manages all operations aspects of clinical research protocols for DFCI Disease Centers. Due to DFCI’s role as the central administrative site for the Dana-Farber/Harvard Cancer Center this position is also responsible for Clinical Trials Budgeting, Clinical Trials Agreements, the Office of Data Quality, and partnering with the Office of Human Research Subjects (responsible for the DFCI IRB) and activities related to protocol review, data management, and clinical trials activation.
Provide proactive leadership and oversee all aspects of clinical research administration and operations support at DFCI.
Develop and oversee short and long-term strategies to support and continually improve the research support needs of clinical investigators at DFCI.
Work with Senior VP, Research Administration to ensure compliance with all policies and guidelines, state and federal regulations, and any other regulatory agency as it relates to clinical research.
Responsible for oversight of the following areas within Research Administration:
Clinical Trials Office, DFCI
Office of Data Quality, DF/HCC
Clinical Trials Budgeting Office, DFCI and DF/MGBCC
Clinical Trials Negotiations Office, DFCI and DF/MGBCC
Work collaboratively with the Sr. Director for the Office of Human Research Studies, DFCI and DF/HCC.
Assess the efficiency and effectiveness of clinical research operations infrastructure at DFCI. Where necessary, improve and enhance the functions such that the scientists and investigators at DFCI are supported.
Work collaboratively with the Associate Director of Clinical Research for DF/HCC and Chief Clinical Research Officer for DFCI as well as Clinical Research Leadership at DF/HCC affiliate organizations to develop strategies for overall process improvement related to protocol review, approval, activation, and clinical trials management.
Responsible for strategic/business planning and evaluation of clinical research support units.
Help develop new strategic plan and business model to recover expenses related to clinical research infrastructure for key services.
Regularly monitors performance vs. plan.
Ensures ongoing compliance with Federal guidelines and institutional policies and procedures.
Develops budgets and revenue forecasts.
Develops appropriate financial models and fee structures, working collaboratively with Research Support Services team, including reviewing fee structures and monitoring usage.
Works with appropriate offices on new service concepts and related planning.
Identifies, analyzes and reports on trends (metrics report).
Identifies and resolves issues.
Seeks opportunities to help control costs and reduce deficits.
Monitors user satisfaction and identifies strategies for improvement.
Develops metrics and regular reports assessing performance of key units such as DFCI Clinical Trials Office, Office of Data Quality, Office of Human Research Subjects, Budgeting and Contracting, and identifies recommendations for improvement.
Work with the Senior Vice President of Research Administration and DF/HCC Associate Director for Clinical Research to make recommendations to the Executive Committee for DF/HCC to improve overall clinical research support process including streamlining processes, improving communications and stronger collaboration.
Work with the Senior Vice President of Research Administration and DFCI Chief Clinical Research Office to implement the approved recommendations of the DFCI President and Executive Committee for Clinical Research. Provide administrative oversight of large, complex research projects for the Institute.
Serves as a senior member of DFCI Research Administration.
Oversee clinical research operations for DFCI and DF/HCC.
Oversee and ensure that DFCI clinical trials administration and operations are efficiently and effectively meeting the needs of clinical investigators at DFCI.
Coordinate and manage the protocol review approval and activation process for DFCI and DF/HCC, including providing support for the Institutional Review Board and Office for Human Research Studies.
Provide oversight for clinical trials administration and operations that support all DF/HCC clinical trials (e.g., patient enrollment and registration, clinical investigation policy and oversight, quality assurance, education, etc.).
Ensure fiscal accountability for all clinical research contracts.
Responsibility for the Clinical Protocol and Data Management, Protocol Review and Monitoring System, and Data Safety Monitoring sections of the Cancer Center Support Grant (CCSG).
Collaborate with the Vice President of DF/HCC Administrative Operations.
Coordinate and facilitate strategies and activities required to assure compliance with CCSG guidelines and in the planning and preparation of CCSG and related grants.
Strategize on efforts to ensure DF/HCC continues to receive the highest possible grant support.
Serves as senior administrator for DF/HCC Clinical Research and other support services provided by DF/HCC to members in order to conduct innovative cancer clinical research.
Serves as administrative liaison between DF/HCC consortium member Clinical Trials Offices and DF/HCC Administration, as well as the DF/HCC Executive Committee.
Serves as a member of the DF/HCC Executive Committee for Clinical Cancer Research.
Serves as administrator to Associate Director of Clinical Research and Medical Director for Clinical Trials for DF/HCC and related committees.
Develops and maintains strong, effective working relationship with Clinical Trials Offices and related research support services. Ensures timely and effective response to constituents and faculty.
Gains full understanding of clinical research operations, services and issues.
Recommends requests by centralized offices for DF/HCC resources.
Develops reputation as Clinical Research advocate.
Analyze and report on key metrics and conducts surveys to assure a high level of researcher satisfaction, and works with Clinical Research offices to prepare annual reports, annual progress reports to the NCI, periodic reports and analysis for senior leadership, and periodic presentations to the Executive Committee and External Advisory Board of the Cancer Center.
Represent Clinical Research issues and help facilitate timely access to needed resources and resolution of issues. Promotion and communication of Clinical Research services to Cancer Center members.
Works with Cancer Center Administration on various projects related to the Cancer Center. Examples include: preparation of NCI grant, assisting with external advisory meetings, participating in administrative database project, developing new research support services, and assisting in special events.
Develops and keeps up to date the DF/HCC Clinical Research policies and procedures.
Develops full understanding of DF/HCC organization, programs, initiatives and activities.
Develops understanding of NCI comprehensive cancer center community and develops relationships with individuals who have similar roles in other NCI cancer centers.
Develops effective working relationships with institutional representatives for DF/HCC and attends coordinating activities.
A minimum of 10 years of relevant experience in a scientific academic health care or like setting.
An advanced degree is preferable (e.g. MBA, MPH, MA/MS, MHA); bachelor's degree required.
Experience in a NCI designated comprehensive cancer center and large academic medical center is preferred.
This job is partial remote, however remote work can only be done from the following states: MA, RI, NH.
Knowledge, Skills, and Abilities Required:
Demonstrated experience leading clinical research operations in a complex organization, including interfacing effectively with multiple faculty and staff with a strong customer service focus.
Demonstrated business, technical and analytic skills. The ability to make sound and creative decisions in a timely manner and to utilize outside resources where appropriate.
Highly knowledgeable about clinical research in an academic medical environment with specific knowledge and expertise in the areas of:
Current and emerging regulatory issues
Grants and contracts from industry, private foundations, and government agencies
Role of sponsors in clinical research
Policy and guideline interpretation, communication, and application
Organizational, project management, quality improvement and operational effectiveness skills.
Strong quantitative, analytic and problem-solving skills to evaluation all aspects of a situation and make appropriate and timely decisions. Proven ability to interpret complex policies and regulations.
Experience in increasing efficiencies and flexibility in the submission, review, and execution research protocols to ensure these processes are performed in the least burdensome manner.
Respects the need to balance the need to conduct innovative research with the need to adhere to external and internal regulations.
Demonstrated ability to directly manage large matrixed teams of administrative staff.
Believes in a service excellence culture.
Exceptional communications, problem solving, consensus building and leadership skills. Highly effective interpersonal skills, a sensitivity to and an understanding of the operational issues, which must be addressed in the management of a complex, research function.
Collaborative; team player.
Experience in working with faculty at all levels. Builds faculty confidence and displays good judgment.
An outstanding manager, a team builder, an individual with a track record of managing an organization through periods of significant change with success. An individual who is able to conceptualize the need for change and communicate that effectively to others in the organization.
Ability to support the ongoing mission and goals of DFCI and DF/HCC.
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.
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 groups as protected by law.