Executive Director, Research Operations

Job Overview The Executive Director of Research Operations provides strategic and operational leadership for oncology and hematology research programs. This role oversees clinical research infrastructure, ensures regulatory compliance, optimizes study execution, and drives growth in sponsored and investigator-initiated trials. Strategic Leadership Develop and execute the long-term strategy for research operations in partnership with research physician leadership. Collaborate with Principal Investigators (PIs), Medical Directors, and disease-specific physician leaders to identify research priorities and expand the clinical trial portfolio. Align operational capabilities with physician-driven scientific vision and program growth goals. Maintain and strengthen the brand integrity of the research program by ensuring excellence in data quality, speed to study start-up, sponsor satisfaction, and overall program profitability. Enhance and grow relationships with key strategic stakeholders, including OneOncology, Tennessee Oncology physicians, and pharmaceutical partners. Represent the research program alongside physician leadership in sponsor meetings, academic collaborations, and industry partnerships. Operational Oversight Partner with physician leadership and OneR to ensure efficient study selection, feasibility assessments, and prioritization of trials. Oversee all clinical research operations, including study start-up, enrollment, conduct, and close-out. Implement, optimize, and manage department-specific technology platforms (e.g., CTMS, eRegulatory systems, and other research software solutions). Establish, track, and continuously refine KPIs across all levels of the research organization, ensuring transparency and accountability. Communicate performance metrics, outcomes, and operational insights to leadership to support continuous improvement. Lead the launch and operationalization of new research sites and locations as the practice expands across Tennessee Oncology. Ensure alignment between clinical care delivery and research workflows to support seamless patient participation. Regulatory, Contracts & Compliance Collaborate with counterparts at OneR to review, negotiate, and approve: Confidentiality Agreements (CDAs/NDAs), Master Study Agreements (MSAs), Clinical Trial Agreements (CTAs), Vendor Service Agreements. Partner with PIs and physician leaders to ensure protocol adherence and appropriate clinical oversight. Ensure adherence to GCP, FDA regulations, IRB requirements, and institutional policies. Maintain audit readiness and oversee responses to regulatory inspections. Team Leadership & Development Provide executive leadership for a large, multi-functional research operations team, including Assistant Directors overseeing key domains (clinical operations, nursing, regulatory, data, finance, quality). Oversee day-to-day research operations through a layered leadership model, ensuring effective execution, operational consistency, and accountability across all functional areas. Lead a structured leadership model, empowering Assistant Directors to manage daily activities while maintaining strategic oversight and alignment with organizational goals. Foster strong collaboration between operational leaders and research physician leadership. Partner with Human Resources to drive strategic workforce planning, including recruiting, succession planning, and team member development across the research organization. Establish and support leadership development programs, career pathways, and retention strategies for high-performing staff. Support physician engagement in research by reducing administrative burden and improving operational efficiency. Build leadership bench strength and ensure continuity through proactive succession planning. Promote a culture of accountability, operational excellence, and continuous improvement across all levels of the organization. Stakeholder Collaboration Serve as the primary operational partner to research physician leadership. Facilitate governance structures (e.g., research steering committees, disease group meetings). Strengthen partnerships with sponsors, CROs, and academic collaborators in conjunction with physician leaders. Communicate success stories, key metrics, operational challenges, and proposed solutions to practice leadership to drive alignment and decision-making. Program Growth & Innovation Co-develop program expansion strategies with physician leadership, including early-phase trials and new therapeutic areas. Support investigator-initiated and physician-led research initiatives. Expand access to clinical trials across community-based settings. Promote innovation in trial design, patient access, and decentralized research models. Knowledge, Skills & Abilities Deep knowledge of clinical trials and regulatory requirements. Strong financial acumen and experience with research budgeting and contracts. Exceptional leadership, communication, and stakeholder management skills. Strategic thinker with the ability to execute operationally. Experience with clinical trial management systems (CTMS), EHR integration, and data analytics tools. Education & Experience Bachelor's degree required. Master’s degree preferred (e.g., Healthcare Administration, Public Health, Life Sciences, Business Administration). 5+ years of experience in clinical research required, with significant focus in oncology and/or hematology preferred. 3+ years of progressive leadership in operational management roles. Demonstrated experience managing large, complex research programs and teams. #J-18808-Ljbffr