Responsibilities:

• 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.  

Qualifications:

• 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.  

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