Job Description

As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.

Job Location (Full Address):

275 Hutchison Rd, Rochester, New York, United States of America, 14627

Opening:

Worker Subtype:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

40

Department:

400295 Cancer Center Admin M&D

Work Shift:

UR - Day (United States of America)

Range:

UR URG 114

Compensation Range:

$86,900.00 - $130,300.00

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Responsibilities:

The Executive Director, Clinical Research Operations (ED) serves as a key enterprise leader responsible for the strategic direction, operational execution, and continuous advancement of clinical research across Wilmot Cancer Institute’s Clinical Research Enterprise. In collaboration with the Associate Director for Clinical Research, Associate Director for Administration, and the Clinical Trials Office (CTO) Medical Director, the incumbent will ensure the development of WCI’s clinical research infrastructure is consistent with expectations of NCI-designated Cancer Centers as outlined in the Cancer Center Support Grant (CCSG) guidelines.

Reporting to senior executive leadership, the ED ensures the delivery of a high-performing, standardized, and patient-centered clinical trials infrastructure that enables equitable access to innovative therapies across all sites of care. This leader is accountable for optimizing trial activation, enrollment, execution, and closeout while maintaining the highest standards of quality, regulatory compliance, and patient safety. The ED partners closely with physician leaders, principal investigators, sponsors, and administrative stakeholders to expand research capabilities, accelerate accrual, and enhance the overall patient and provider experience.

ESSENTIAL FUNCTIONS

Enterprise Strategy & Operational Leadership

• Define and execute a comprehensive, systemwide strategy for clinical trial operations that aligns with Wilmot’s strategic priorities and NCI designation requirements.
• As the primary operational leader, lead the design, standardization, and scaling of workflows, infrastructure, and technologies to support efficient and high-quality trial delivery.
• Drive integration of clinical research into care delivery models to ensure trials are accessible, scalable, and embedded across all regions.
• Establish governance structures, performance dashboards, and reporting mechanisms to ensure transparency, accountability, and continuous improvement.
• Represent clinical trial operations in executive forums and contribute to enterprise-wide strategic planning initiatives.
• Translate scientific and programmatic priorities set by the cancer center director and associate director for clinical research into actionable operational strategies.
• Anticipate and respond to shifts in the clinical trials landscape (e.g. NCTN, NCORP, ETCTN, industry-sponsored, IIT) to keep the portfolio competitive and diversified.

Stakeholder Engagement & Collaboration

• Build and sustain strong partnerships with disease program leadership, principal investigators, clinical and operational leaders, foundation leadership, and industry sponsors.
• Serve as a key liaison between research, clinical operations, finance, and administrative functions to ensure alignment and shared accountability.
• Strengthen external relationships with sponsors and partners to enhance study opportunities, improve activation timelines, and expand the research portfolio.
• Partner closely with the associate director for clinical research on scientific prioritization, protocol portfolio balance, and trial accrual strategy.
• Collaborate with the associate director for administration on applicable budget alignment, space planning, and institutional resource allocation.

Clinical Research Execution & Quality Oversight

• Establish and enforce systemwide standards for study start-up, conduct, monitoring, and closeout, ensuring compliance with all regulatory and accreditation requirements with FDA, ICH-GCP, NCI. OHRP, and institutional regulatory office.
• Oversee the development and implementation of standard operating procedures (SOPs), quality assurance programs, and audit readiness processes.
• Ensure consistent delivery of safe, ethical, and high-quality research, with a strong focus on patient experience and outcomes.
• Identify operational bottlenecks and implement scalable solutions to improve trial activation speed, enrollment, and data integrity.
• Serve as a liaison between the CTO and supporting institutional entities, including IRB, PRMC, Pharmacy, Tissue bank, Pathology, Radiology, and DSMC.
• Oversee clinical trial agreement negotiation, budget development, and coverage analysis in coordination with Sponsored Programs and Administration.
• Maintain oversight of clinical research information systems (CTMS, OnCore, EDC platforms etc. to ensure accurate, real-time portfolio tracking.

People & Talent Leadership

• Provide executive oversight of clinical research personnel across the system, including workforce planning, recruitment, retention, and succession planning.
• Foster a culture of accountability, collaboration, and continuous learning among research staff and leadership.
• Develop and implement comprehensive onboarding, training, and professional development programs to ensure staff are highly skilled and compliant with evolving regulations.
• Coach and mentor leaders to build a strong, sustainable pipeline of talent.
• Establish career ladders, competency frameworks and professional development pathways to strengthen workforce capability and retention

Financial Stewardship & Growth

• Oversee the financial performance of clinical trial operations, including budgeting, forecasting, and resource allocation and report financial performance and portfolio growth metrics to cancer center leadership and relevant oversight committees,
• Identify opportunities to improve operational efficiency, optimize cost structures, and enhance revenue generation through research activities.
• Collaborate with finance and business development teams to evaluate and launch new programs, services, and partnerships that support research growth.
• Monitor per-patient trial costs and negotiate sponsor budgets to ensure financial sustainability of trial conduct.

Performance Improvement, Analytics & Innovation

• Define key performance indicators (KPIs) and leverage data analytics to monitor performance, identify trends, and inform decision-making.
• Lead systemwide quality and performance improvement initiatives aimed at increasing trial access, enrollment, and operational efficiency.
• Champion innovation in clinical trial delivery, including decentralized trials, digital tools, and novel care models.
• Ensure alignment of trial portfolios with patient population needs, organizational capabilities, and strategic priorities.
• Benchmarks performance against peer NCI-designated cancer centers and national best practices.

Clinical Research Care Coordination & Access

• Promote a coordinated, patient-centered approach to clinical research across all sites, ensuring seamless integration with clinical care pathways.
• Align trial availability with disease prevalence, community needs, and site capabilities to improve equitable access to research in collaboration with marketing/communication to raise awareness of trial availability among patients, providers, and the community.
• Partners with clinical and administrative leaders to remove barriers to participation and enhance patient engagement in trials.

MINIMUM EDUCATION & EXPERIENCE

• Master's degree and 5 years of relevant experience required
• Or equivalent combination of education and experience
• 2 years in a managerial capacity required
• 10+ years of clinical trial experience with 5+ years of managerial level with significant experience in an academic medical center or NCI-designated cancer center setting preferred.
• Evidence of progressive leadership experience preferred
• Knowledge and/or experience with NCI CCSG expectations preferred
• Direct experience with clinical trial management systems such as OnCore, Velos, Clinical Conductor, etc preferred.
• Previous experience coordinating and managing oncology clinical research programs preferred

KNOWLEDGE, SKILLS AND ABILITIES

• Extensive knowledge in clinical research operations and associated regulations governing clinical research preferred
• Strong interpersonal and relationship-building skills to engage physicians, scientists, administrators, and external sponsors preferred
• Strong financial acumen, including budget development, forecasting, and cost/revenue management preferred
• Exceptional strategic thinking and ability to translate institutional priorities into operational execution preferred
• Strong communication skills (verbal and written) preferred
• Ability to provide leadership and promote collaboration preferred
• Possess exceptional time management skills preferred
• Excellent interpersonal skills preferred

The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University’s Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.