About this opportunity
OnKure Therapeutics lists this Associate Director, Clinical Operations opportunity in boulder, Colorado. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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, elevate, 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%
About OnKure
We are a clinical‑stage biopharmaceutical company focused on discovering and developing precision medicines that target biologically validated drivers of diseases underserved by available therapies. Using a structure‑and computational chemistry‑driven drug design platform, we are committed to improving clinical outcomes for patients by building a robust pipeline of small‑molecule drugs designed to selectively target specific mutations thought to be key drivers of cancer and vascular anomalies.
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.
OnKure is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, protected veteran status, disability, or any other protected factors.
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Worksite address
boulder, CO, 80301, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.