09/24/2026
Director, Clinical Operations – Oncology
Morris County, NJ (onsite 3 days)
Our client, an innovative biopharmaceutical company, is seeking a strategic and experienced Director of Clinical Operations to join their Oncology Therapeutics Group. In this role, you will oversee the operational strategy, financial management, and ex*****on of early-phase (Phase I/II) clinical trial portfolios.
As a key leader, you will manage a large team of direct and indirect clinical operations professionals, champion organizational change, and drive continuous process improvements. You will serve as the primary Clinical Operations voice on global program strategy teams, ensuring complex trials and multi-study programs are delivered efficiently, on time, and within budget.
Key Responsibilities:
Strategic Leadership: Provide operational oversight for oncology pipelines and clinical teams. Streamline study workflows and timelines while maintaining uncompromising quality standards.
Cross-Functional Representation: Act as the clinical operations lead on cross-functional asset strategy and study design teams. Contribute operational insights that shape the broader clinical development plan.
Alliance & Stakeholder Management: Foster strong collaborations with global internal stakeholders and external partners. Keep leadership appropriately updated on milestone progress, operational risks, and key milestones.
Risk Mitigation: Proactively identify and evaluate potential project constraints, budgetary issues, or clinical risks before they impact deliverables. Develop proactive mitigation strategies.
Study Integrity & Endpoint Delivery: Leverage a deep understanding of patient recruitment journeys, trial design, data collection, and statistics to safeguard the quality and evaluability of clinical endpoints.
CRO & Vendor Management: Oversee Contract Research Organizations (CROs) and third-party vendors by setting clear KPIs, driving performance accountability, and addressing delivery issues early.
People & Resource Management: Recruit, mentor, and retain a diverse, high-performing team of clinical professionals and people managers. Establish clear performance metrics and handle resource forecasting for the program.
Process Optimization: Spearhead clinical ops standardization, develop SOPs, and incorporate industry best practices across the department.
Business Development Support: Provide clinical operations expertise during due diligence, corporate asset reviews, or vendor governance discussions as needed.
Required Qualifications & Experience:
Education: Bachelor’s, Master’s, PharmD, or PhD degree in Life Sciences or a related scientific field.
Experience: Minimum of 10+ years of relevant clinical operations experience within the pharmaceutical, biotech, or CRO industry.
Oncology Expertise: Direct, hands-on experience managing company-sponsored oncology clinical trials is mandatory.
Leadership Track Record: Proven experience managing high-complexity clinical programs, handling long-range strategic resource planning, and directing line management (ideally managing other managers/indirect reports).
Vendor Operations: Demonstrated success in developing RFPs, selecting CROs, and enforcing effective oversight structures to ensure on-time, on-budget delivery.
Regulatory Knowledge: Deep understanding of global regulatory landscapes, including FDA, EMA, ICH, and Good Clinical Practice (GCP) guidelines.
Financial Acumen: Strong proficiency in developing, tracking, and forecasting complex clinical trial and program-level budgets.
Soft Skills: Exceptional communication and change-management skills. Proven ability to influence without authority, resolve conflicts constructively, and present to executive steering committees.
Travel: Ability to travel nationally and internationally as required by project needs.
Please contact Darren Gutowski at [email protected]