Our success is rooted in our exceptional team, and we are always looking for passionate, talented individuals to join us. We believe in sharing our success with everyone who contributes, which is why we grant stock options to every employee.
We are building a first-class team in the US. Our team shares the desire to deliver hope to cancer patients worldwide. We offer a flexible hybrid and remote structure and excellent health and financial benefits. Explore our job openings below.
• Lead the end-to-end operational management of assigned clinical trials, ensuring timely initiation, enrollment, execution, and close-out.
• Act as the primary clinical operations lead on cross-functional study teams.
• Support clinical development strategy by providing input on study design, site selection, and operational feasibility.
• Own and manage clinical trial budgets, including initial budget development, forecasting, accruals, and variance analysis.
• Lead contract and budget negotiations with CROs, vendors, and clinical sites.
• Review and approve vendor contracts, scopes of work, change orders, and payment terms in partnership with Finance.
• Monitor financial performance to ensure alignment with overall program goals and OnCusp’s operational strategy.
• Manage CROs and third-party vendors to ensure quality execution and compliance with timelines and deliverables.
• Define and track key performance indicators (KPIs) to assess vendor performance.
• Provide proactive oversight and issue resolution across vendor relationships.
• Support and mentor clinical operations team members and contribute to building a highperforming Clinical Operations function.
• Contribute to the development, implementation, and refinement of Clinical Operations SOPs and best practices.
• Support inspection readiness and quality compliance through risk-based monitoring and internal audit support.
• Partner with Clinical Development, Clinical Science, Regulatory, Translational, and Project Management to align operational execution with strategic goals.
• Contribute to the development of key study documents (protocols, informed consents, monitoring plans, trial master files, etc.).
• Ensure timely and quality data delivery and collaborate on clinical data review and database lock processes.
• Maintain strong relationships with clinical sites and investigators to ensure proactive engagement and recruitment support.
• Participate in clinical site feasibility, selection, and activation activities.
• Support communications with KOLs, regulatory authorities, and external partners as needed.
• Bachelor's degree in a life sciences field required; advanced degree (MS, MPH, PharmD, or equivalent) preferred.
• 10+ years of experience in clinical operations, with at least 5 years in oncology trials and global program execution.
• Demonstrated experience in clinical trial budgeting, financial tracking, and contract negotiations.
• Strong knowledge of ICH GCP, FDA, and EMA regulations.
• Operates with urgency, ownership, and accountability.
• Comfortable in a lean, high-growth biotech setting where strategic thinking is balanced with hands-on execution.
• Flexible and adaptive; able to pivot and problem-solve in real-time.
• Proven ability to manage and lead in a cross-functional, matrixed environment.
• Hands-on experience with allphasees (FIH/Phase I-IV) clinical trials preferred.
• Excellent organizational, interpersonal, and communication skills.
• Ability to travel domestically and internationally as needed.
