Associate Director of Clinical Research (IIT & Program Strategy Focus) - Radiation Oncology

Location: St. Louis, MO 63108 | Scheduled Hours: 40

About the Role

The Department of Radiation Oncology at Washington University School of Medicine is seeking a highly experienced, strategic, and systems-oriented Associate Director of Clinical Research Operations. Under the direct guidance of the Department Chair / Interim Clinical Trials Director and the Executive Director of Business Affairs, this individual will serve as the primary operational leader for the expansive clinical trials enterprise. As the department enters a new phase of strategic growth, a primary mandate of this role will be the rapid expansion, standardization, and oversight of the Investigator-Initiated Trials (IIT) portfolio, including landmark multi-disciplinary grants (e.g., ROBIN U54 center) and pioneering global protocols in SBRT and cardiac radioablation. The successful candidate will bring a systems-oriented approach to process improvement, empowering teams while promoting consistency, compliance, and high-quality execution across all phases of oncology research.

Responsibilities

• IIT Program Expansion & Leadership: Lead the strategic growth of the department's Investigator-Initiated Trials (IIT) portfolio. Support principal investigators through concept development and governance review, and oversee the operational execution of complex early-phase and multi-center oncology studies.
• Operational Leadership & Mentorship: Direct the day-to-day operations of the Clinical Trials Office, including the direct supervision, mentorship, and performance evaluation of the Clinical Research Manager. Oversee cross-functional teams, manage critical paths, and ensure staffing strategies align with program-level planning. Design and implement career development pathways to improve research staff retention and engagement. Partner collaboratively with existing departmental research leadership during the initial onboarding phase to ensure a seamless transfer of historical institutional knowledge and trial continuity.
• Systems Integration & Process Optimization: Lead the implementation and optimization of enterprise research systems, including EDC and eRegulatory platforms. Assess institutional system capabilities to determine feasibility and drive EHR-to-EDC integration initiatives to reduce manual data entry and improve data integrity.
• Program Budget & Financial Forecasting: Oversee the clinical trials program budget and partner with department finance and research administration on financial forecasting. Develop advanced project and financial tracking tools (e.g., Smartsheet dashboards) to enhance leadership visibility into timelines, workloads, budgets, and accrual performance.
• Strategic Institutional Collaboration: Foster strong, collaborative relationships with key institutional partners across Washington University and BJC HealthCare (e.g., CTMS offices, Biorepositories, Research Administration, and hospital/laboratory groups) to streamline workflows and overcome institutional bottlenecks.
• Regulatory Compliance & Quality Assurance: Overhaul and maintain program SOPs and guidance documents. Ensure all trials maintain strict compliance with FDA, ICH/GCP, and OHRP regulations. Manage site feasibility, qualification, and oversight for multi-center studies.

Requirements

• Bachelor’s degree in biological sciences, healthcare administration, public health, nursing, business, or a related field.
• Eight years of progressive leadership experience in clinical research operations and program management, strictly within an academic medical center or complex oncology setting.

Qualifications

• Preferred Education: Master’s degree (MHA, MPH, MBA, or MSN).
• Preferred Experience:
  • Five years of direct personnel management, including experience supervising mid-level managers.
  • Exceptional cross-functional leadership skills with the ability to manage complex, multi-site investigator consortia.
  • Extensive, proven expertise in managing, scaling, and operationalizing Investigator-Initiated Trials (IIT) and early-phase oncology portfolios.
  • Demonstrated experience leading the rollout of enterprise research platforms (EDC/eReg) and developing advanced project tracking tools/dashboards.
  • Expert-level knowledge of FDA, ICH/GCP, and OHRP regulations.
  • Proven track record of building collaborative structures that support innovation and process improvement.
• Preferred Certifications: Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), Clinical Research Associate (CRA), Clinical Research Management (CRM), Clinical Research Professional (CRP), or Registered Nurse (RN).

Skills

• Building High Performance Team
• Clinical Research
• Clinical Research Operations
• Clinical Research Organizations (CRO) Management
• Clinical Trials
• Compliance Management
• Data Reporting
• Diplomacy
• External Stakeholders
• Financial Acumen
• Grants Management
• Grant Writing
• Internal Stakeholders
• Interpersonal Communication
• Leadership
• Project Planning
• Protocol Development
• Regulatory Submissions
• Standard Operating Procedure (SOP) Development
• Strategic Planning

Working Conditions

• Normal office environment.
• Typically sitting at a desk or table.
• Use of office equipment.

Pay

Salary Range: $84,200.00 - $148,500.00 / Annually

Benefits

• Personal:
  • Up to 22 days of vacation, 10 recognized holidays, and sick time.
  • Competitive health insurance packages with priority appointments and lower copays/coinsurance.
  • Free Metro transit U-Pass for eligible employees.
  • Defined contribution (403(b)) Retirement Savings Plan, combining employee contributions and university contributions starting at 7%.
• Wellness:
  • Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more.
• Family:
  • 4 weeks of caregiver leave to bond with a new child.
  • Family care resources for childcare needs.
  • Adult care resources.
  • Tuition coverage for employees and their families, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years.