Reports to: Chief Development Officer
We are seeking an accomplished Head of Clinical Operations to lead the strategic planning, execution, and oversight of global clinical development programs for a clinical-stage oncology biotechnology company. This executive will be responsible for building and leading a high-performing clinical operations organization, ensuring the successful execution of clinical trials from study start-up through database lock and regulatory submission.
The ideal candidate is an experienced clinical operations leader with a demonstrated track record of advancing oncology programs across multiple phases of development while maintaining the highest standards of quality, compliance, and operational excellence.
- Develop and execute the global clinical operations strategy aligned with corporate development objectives.
- Provide leadership and oversight for all aspects of clinical trial execution, including planning, feasibility, site activation, enrollment, monitoring, vendor oversight, and study closeout.
- Build, mentor, and lead a high-performing clinical operations team while fostering a culture of accountability, collaboration, and continuous improvement.
- Oversee CROs and strategic vendors, establishing performance metrics and ensuring delivery against timelines, quality standards, and budgets.
- Partner closely with Clinical Development, Medical Affairs, Regulatory Affairs, Biometrics, Clinical Supply, Quality Assurance, Translational Medicine, and Program Management to ensure seamless execution of clinical programs.
- Lead operational planning for global, multicenter oncology studies, proactively identifying risks and implementing mitigation strategies.
- Ensure compliance with ICH-GCP guidelines, applicable regulatory requirements, SOPs, and quality standards.
- Develop and manage clinical operations budgets, resource planning, forecasting, and financial oversight.
- Support clinical development strategy through operational input on protocol design, country selection, feasibility assessments, and study execution plans.
- Contribute to due diligence activities, portfolio planning, and business development evaluations as needed.
- Represent Clinical Operations in governance committees, leadership meetings, and interactions with external partners.
- Bachelor's degree in a scientific discipline required; advanced degree (MS, PharmD, PhD, RN, or equivalent) preferred.
- 15+ years of progressive clinical operations experience within biotechnology and/or pharmaceutical organizations.
- Significant leadership experience managing global oncology clinical trials, including Phase I III studies.
- Demonstrated success leading clinical operations teams in a fast-paced biotechnology environment.
- Deep understanding of oncology drug development, clinical trial regulations, ICH-GCP, FDA, EMA, and international regulatory requirements.
- Strong expertise in CRO selection, vendor management, and strategic outsourcing models.
- Experience managing complex clinical trial budgets and resource planning.
- Excellent leadership, communication, organizational, and cross-functional collaboration skills.
- Proven ability to influence executive leadership and drive operational excellence across multiple development programs.
- Experience supporting first-in-human and early clinical oncology programs.
- Prior experience in a clinical-stage biotechnology company.
- Experience supporting regulatory inspections and clinical quality initiatives.
- Familiarity with precision medicine, biomarker-driven trials, and innovative oncology study designs is highly desirable.
- Strategic thinker with strong execution capabilities.
- Collaborative and transparent leadership style.
- Exceptional organizational and project management skills.
- Strong decision-making and problem-solving abilities.
- Ability to thrive in a dynamic, entrepreneurial biotechnology environment.
- Passion for improving outcomes for patients with cancer.
This is a highly visible leadership position reporting directly to the Chief Development Officer and will play a critical role in advancing the organization's oncology pipeline through operational excellence and effective cross-functional leadership.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
