What are the responsibilities and job description for the Vice President Clinical Operations - Oncology position at Helios CR, Inc?
Vice President of Clinical Operations – Oncology
Department: Oncology Clinical Operations
Reports To: Chief Operating Officer (COO)
Location: West-Coast Preferred (Travel throughout all Oncology clinics required)
Position Summary
The Vice President of Clinical Operations – Oncology is responsible for providing strategic leadership, operational oversight, and clinical excellence across Helios Clinical Research's oncology research sites throughout initially California, Florida and Arizona with expansion planned into other states. This executive leader drives operational performance, ensures regulatory compliance, supports business growth, and partners closely with physicians, sponsors, CROs, and executive leadership to deliver high-quality clinical research while maintaining exceptional patient care.
The Vice President serves as a key member of the executive leadership team, developing scalable operational strategies that support Helios' mission of advancing oncology research through innovation, quality, and operational excellence.
Executive Leadership
• Provide strategic leadership and direction for all oncology clinical operations.
• Develop and execute operational strategies aligned with organizational goals.
• Foster a culture centered on patient safety, quality, accountability, and continuous improvement.
• Serve as a trusted advisor to executive leadership regarding clinical operations and site performance.
• Lead organizational initiatives, change management efforts, and operational integrations.
Clinical Operations
• Oversee the day-to-day operations of multiple oncology research clinics.
• Ensure consistent execution of clinical research protocols while maintaining exceptional patient care.
• Establish operational standards and best practices across all Oncology sites.
• Monitor operational metrics including patient enrollment, study activation timelines, visit completion, protocol compliance, site productivity, and financial performance.
• Develop corrective action plans when operational goals are not achieved.
• Drive continuous improvement initiatives to increase efficiency and study performance.
Physician & Site Leadership
• Partner closely with Principal Investigators and Sub-Investigators to ensure successful study execution.
• Build strong relationships with physician leadership and clinic management.
• Support physician engagement in new study opportunities.
• Resolve operational issues impacting patient care or study execution.
• Promote collaboration across physicians, coordinators, regulatory, pharmacy, laboratory, and business departments.
Regulatory & Quality Compliance
• Ensure compliance with FDA regulations, ICH-GCP Guidelines, Oncology requirements, sponsor requirements, IRB requirements, and company SOPs.
• Collaborate closely with Regulatory Affairs and Quality Assurance.
• Support FDA inspections, sponsor audits, and internal quality reviews.
• Implement corrective and preventive actions (CAPAs).
• Promote a culture of quality and regulatory excellence.
Financial & Business Operations
• Develop and manage operational budgets.
• Monitor clinic profitability and financial performance.
• Partner with Finance regarding revenue forecasting, staffing models, and operational efficiencies.
• Support business development efforts and evaluate operational feasibility of new opportunities.
• Assist in site expansion, acquisitions, and integration initiatives.
Leadership & Talent Development
• Lead, mentor, and develop Directors, Site Operations Managers, Clinical Managers, and operational leaders.
• Establish performance expectations and accountability measures.
• Conduct performance evaluations and coaching.
• Support succession planning, recruitment, retention, and employee development.
Cross-Functional Collaboration
Partner with Executive Leadership, Medical Directors, Principal Investigators, Regulatory Affairs, Quality Assurance, Human Resources, Finance, Business Development, Information Technology, Sponsors, and CROs to ensure operational excellence.
Strategic Growth
• Evaluate operational readiness for new oncology studies.
• Support expansion into new therapeutic areas.
• Assist with mergers, acquisitions, and integration of new research sites.
• Identify innovative technologies and operational improvements.
• Develop long-term strategic plans to increase operational efficiency and market growth.
Qualifications
• Bachelor's degree in Nursing, Healthcare Administration, Life Sciences, or related field required.
• Master's degree (MBA, MHA, MSN, MPH, or similar) strongly preferred.
• Minimum 10 years of progressive clinical research leadership experience.
• Minimum 5 years leading multi-site oncology clinical operations.
• Executive leadership experience preferred.
• Experience working directly with Principal Investigators and oncology physicians.
• Experience with FDA inspections and sponsor audits.
Knowledge, Skills & Abilities
• Extensive knowledge of FDA regulations, ICH-GCP, oncology clinical trials, and clinical research operations.
• Strong business and financial acumen.
• Excellent leadership, communication, organizational, and project management skills.
• Ability to analyze operational metrics and implement strategic improvements.
• Ability to build strong relationships with physicians, sponsors, and executive leadership.
Travel Requirements
Frequent travel throughout Oncology clinics (approximately 40–60%) with occasional domestic travel for sponsor meetings, conferences, and executive leadership meetings.
Physical Requirements
Ability to travel between sites, use standard office equipment, and occasionally lift up to 20 pounds.
Why Join Helios Clinical Research?
At Helios Clinical Research, we are committed to advancing oncology research while delivering exceptional patient care. Our leaders are empowered to drive innovation, inspire high-performing teams, and help bring life-changing therapies to patients.