Executive Director, Clinical Research Operations

Wilmot

Full time

R274378

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 - $

_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…