OnKure is seeking an Associate Director, Clinical Operations. This is a key cross-functional leadership position within the Clinical Operations organization. This role is responsible for providing operational leadership and strategic input for the planning, successful execution, oversight, and delivery of clinical trials and clinical development programs across all phases of development and is accountable for CRO and vendor oversight, budget management, risk mitigation, and inspection readiness.

The Associate Director ensures studies are conducted on time, within budget, and in compliance with applicable regulatory requirements, Good Clinical Practice (GCP), company policies, and quality standards to support global regulatory submissions and product development objectives.

Job Responsibilities:

Clinical Trial Execution

• Lead the operational planning, execution, and oversight of clinical trials from study start-up through closeout
• Develop and oversee study timelines, operational plans, , and study-level performance metrics; proactively identify and mitigate risks to ensure successful study delivery
• Drive subject enrollment, retention, and study completion according to program timelines, key study milestones and development objectives
• Lead cross-functional clinical study teams and foster collaboration across Clinical Development, Medical Affairs, Regulatory Affairs, Data Management, Biostatistics, Pharmacovigilance, Clinical Supply, and Quality Assurance
• Collaborate with Data Management and Biostatistics teams to support data quality, database lock, and study reporting activities
• Ensure clinical data are collected, monitored, and managed according to approved monitoring plans and data quality standards
• Contribute to the development and review of key clinical documents, including protocols, informed consent forms, Investigator Brochures (IBs), Development Safety Update Reports (DSURs), Clinical Study Reports (CSRs), and study manuals

CRO and Vendor Management

• Develop Requests for Proposals (RFPs), define scopes of work, and participate in vendor selection and contracting activities
• Provide strategic oversight of external service providers (i.e., CROs, central laboratories, imaging vendors, etc.)
• Establish performance expectations and key performance indicators (KPIs), monitor vendor performance against quality, timeline, and budget objectives and proactively identify risks and implement mitigation strategies
• Manage vendor governance processes, escalation pathways, and issue resolution activities
• Review and approve change orders, budget modifications, and vendor deliverables
• Build collaborative partnerships with CROs and vendors to ensure high-quality study execution and continuous operational improvement

Financial and Resource Management

• Assist in or independently manage the development and forecasting of study budgets, accruals and variance analysis to identify opportunities for process efficiencies and cost optimization
• Ensure effective utilization of resources while maintaining operational excellence and fiscal responsibility
• Monitor budget performance and proactively identify, escalate, and mitigate financial risks

Quality, Compliance, and Inspection Readiness

• Ensure clinical trials are conducted in compliance with ICH-GCP, applicable regulatory requirements, company SOPs, and quality standards
• Implement risk-based quality management principles and oversee study-level risk assessment and mitigation activities
• Ensure inspection-ready with study documentation throughout the study lifecycle
• Review protocol deviations, monitor trends, and drive appropriate corrective and preventive actions (CAPAs)
• Support internal audits, regulatory inspections, and sponsor oversight activities
• Escalate significant quality or compliance issues and partner with Quality Assurance to drive resolution

General:

• Foster a culture of accountability, collaboration, innovation, quality, and continuous improvement
• Contribute to departmental process improvements, SOP development, and organizational best practices

Preferred Experience and Qualifications:

• Bachelor's degree or higher in Life Sciences, Nursing, Pharmacy, or a related scientific discipline required
• Minimum of 10 years of progressive clinical operations experience with at least 7 years of experience within biotechnology, pharmaceutical, or CRO environments
• Demonstrated experience leading Phase I-IV clinical trials and/or clinical development programs
• Oncology and/or rare disease experience preferred
• Significant experience managing CROs, vendors, and global clinical trial operations
• Experience in leading studies in a dynamic, small biotech company environment with smaller functional teams is highly desired
• Prior people management experience preferred
• Comprehensive knowledge of ICH-GCP guidelines, FDA regulations, EMA regulations, and global clinical trial requirements
• Strong understanding of risk-based quality management, inspection readiness, and clinical trial governance
• Excellent project management, organizational, and strategic planning skills with commitment to quality, compliance, and continuous improvement
• Demonstrated ability to independently lead multiple studies and priorities in a fast-paced environment
• Strong analytical and problem-solving capabilities with a proactive, solution-oriented approach
• Exceptional leadership to build effective cross-functional relationships
• Excellent written, verbal, and presentation communication skills
• Proficiency with clinical trial systems, TMF platforms, CTMS, EDC systems, and Microsoft Office applications
• Travel up to 20%

To attract the very best talent, OnKure offers a generous compensation and benefits package that includes competitive pay, performance-based bonus opportunities, stock options, insurance coverage (health, dental, life, and disability) for full-time employees, self-managed paid time off, and a 401(k) plan with company match. Candidates who live in or are willing to relocate to the Boulder, CO area are preferred.

The annual compensation range for this role, based on experience, is $175,000-$210,00. Job level and compensation are dependent on relevant education and experience.