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URMC / Center for Health + Technology / Careers / CTCC Director Position

Director of the Clinical Trials Coordination Center

The Center for Health + Technology (CHeT) is a research organization within the University of Rochester that aims to enable anyone anywhere to receive care and participate in research. To do so, CHeT employs over 80 talented and diverse individuals to conduct unprecedented studies to evaluate new treatments and measures of disease. Over the past 30 years, CHeT has conducted over 100 studies and enrolled over 40,000 participants, leading to seven FDA-approved drugs for Parkinson’s disease, Huntington disease, and other neurological conditions.

Responsibilities

CTCC has been at the forefront of clinical trials for neurological conditions, which are now the world’s leading source of disability. We are looking for someone interested in helping the CTCC be a pioneer in the future of clinical trials. This role will research and evaluate the changing national and international marketplace related to scientific trends and competitive solutions and will translate knowledge of the business and services to meet strategic goals. Specific responsibilities include the following:

  • Oversee all aspects of clinical trial operations, including project management, data management, monitoring, finance and administration, project prioritization, resource allocation, and day-to-day operations efficiency, including:
    • Responsible for the overall direction of the Clinical Trials Coordination Center (CTCC) and the national, as well as international, study groups it supports (PSG/HSG/others) mission, its growth and diversification strategy, including final decisions about which projects the CTCC will manage.
  • Responsible for the overall prioritization of projects and overall resource allocation. This includes responding to NIH and non-profit foundation grants and requests for proposals for projects with biopharmas and other sponsors. (20%)
  • Responsible for the overall efficient day-to-day operations of the CTCC. Collaborate with faculty, senior leadership, and others in adapting and developing strategic plans. Plan and direct administrative and other support mechanisms. Prepare analyses and reports; and make recommendations for programs and policies. Resolve data sharing issues and data use agreements; review specific accounts and respond to requests for applications working with Subject Matter Experts (SME’s) with that specific disease to develop template language. (20%)
  • Drive key strategic initiatives, including (20%):
    • Recruiting, developing, training, and retaining strong talent
    • Driving improvements in infrastructure, technologies, operating systems, and processes for clinical trials management
    • Developing and executing strategic technology roadmap that enable efficient operations
    • Delivering transparency into operations – e.g., self-serve reporting for client, timeline/resource dashboard to manage project timeline and optimize resource allocation
  • Work with department’s Financial Controller and finance and administration teams to monitor and evaluate overall CTCC finances, including project scope and budgets, change orders/contract amendments, and overall resources (personnel and space). In collaboration with Controller, prepare, recommend and control budgets; prepare long range forecasts; approve expenditures, and reallocate funds. (15%)
  • Management of the performance and productivity of CTCC Functional Directors, including but not limited to Director: Project Management, Data Management, and Monitoring and Regulatory Services. (10%)
  • Establish and cultivate relationships with and market services to potential customers including academic, non-profit/foundation, government, and biopharmaceutical companies. Represent the CTCC to professional organizations, in cooperative programs with other institutions, sponsors, entities or funding negotiations with public or private organizations (10%)
  • Additional projects and responsibilities as needed (5%)

Requirements

  • Masters degree or higher in health or life sciences related field, Business Administration, or equivalent experience in a specialty suited to the position
  • A minimum of 8 years’ experience in clinical research, biopharma drug development/ and/or healthcare industry experiences. At least 10+ years of experience in the industry strongly preferred
  • Minimum of 8 years of proven, effective strategic planning; analytical problem solving and decision making; managerial and leadership skills and experience; or equivalent combination of experience and education
  • Strong analytical and finance administration knowledge with managing budgets
  • Strong organizational, interpersonal, presentation and communication skills, including written communications
  • Strong acumen to understand and drive adoption of technologies, in particular clinical data management, data visualization, and statistics in clinical trials preferred
  • Ability to model leadership skills of professionalism, positive attitude, team building, good judgment and respect
  • Ability to manage multiple projects, organize and prioritize work and perform several tasks simultaneously to meet deadlines and work effectively with people at all levels of the organization
  • Good understanding of regulatory requirements (e.g., GCP, HSPP, ICH) and Audit readiness
  • Strong ability to build relationships; contacts within the industry and academic peer groups; and ability to collaborate across functional areas and departments

Questions

If you have any questions about this position, reach out to Norman Yung, Chief Operating Officer of the Center for Health + Technology, at norman.yung@chet.rochester.edu.

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