VP / Head of Clinical Operations

About the role

A growing, early-stage oncology biotech company is seeking an experienced VP / Head of Clinical Operations to provide strategic and operational leadership across multiple ongoing Phase 1 oncology clinical programs. This individual will play a critical role in advancing early-phase studies by driving execution, overseeing vendors and CROs, managing timelines and budgets, and helping scale the clinical operations function within a lean, fast-paced organization. This is an excellent opportunity for a hands-on clinical operations leader who thrives in entrepreneurial biotech environments and is comfortable rolling up their sleeves to support company-wide objectives. The role offers the potential to transition from contract to permanent employment for the right candidate.

Responsibilities

• Provide strategic oversight and leadership for multiple early-phase oncology clinical trials (Phase 1, Phase 2a, and Phase 2b).
• Lead and direct all clinical operations activities to ensure successful study execution, quality, timelines, and budget adherence.
• Manage and oversee CROs, vendors, and external partners to ensure performance, compliance, and operational excellence.
• Develop and maintain clinical study plans, timelines, risk mitigation strategies, and operational metrics.
• Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Data Management, Biometrics, Medical Affairs, and other key stakeholders.
• Drive operational readiness for study start-up, enrollment, data collection, and closeout activities.
• Establish and optimize clinical operations processes, infrastructure, and best practices to support company growth.
• Monitor program budgets, forecasts, and resource allocation across the clinical portfolio.
• Ensure inspection readiness and compliance with GCP, ICH guidelines, and applicable regulations.
• Mentor and support clinical operations team members and contribute to organizational scaling efforts.

Requirements

• Bachelor's degree in life sciences or related field; advanced degree preferred.
• Significant clinical operations leadership experience within biotechnology and/or pharmaceutical companies.
• Prior experience serving as a Head of Clinical Operations, VP Clinical Operations, or equivalent senior clinical development leadership role.
• Demonstrated success managing early-phase oncology clinical trials, including Phase 1 studies.
• Strong background in immuno-oncology and solid tumor programs.
• Extensive experience overseeing CROs, vendors, and external clinical partners.
• Proven track record managing clinical trial timelines, budgets, and operational execution.
• Experience building, scaling, and optimizing clinical operations organizations.
• Ability to work effectively in a small, dynamic biotech environment with limited infrastructure.
• Excellent leadership, communication, collaboration, and problem-solving skills.

Skills

• Experience with early-stage oncology biotech companies.
• Background supporting investigational therapies in immuno-oncology and solid tumor indications.
• Previous experience transitioning organizations through growth and clinical expansion.
• Proximity to the Greater Philadelphia area and ability to periodically attend onsite meetings preferred.