Senior Clinical Operations Lead - Trials and CRO Oversight

OnKure Therapeutics; Boulder (CO); On-site; USD 175,000 - 210,000; Full time

Benefits offered by this job

Stock options

Health insurance

Dental insurance

Life insurance

Disability insurance

Paid time off

401(k) match

Relocation assistance

Job summary

OnKure Therapeutics in Boulder, CO seeks an Associate Director, Clinical Operations to provide operational leadership for planning and delivering clinical trials across all phases. The role oversees CROs, vendors, budgets, risk mitigation, and inspection readiness, ensuring trials run on time, within budget, and in compliance with GCP and company standards.

You will lead cross‑functional teams, develop study timelines, manage budgets, and drive data quality.

Qualifications

• Bachelor's degree or higher in Life Sciences, Nursing, Pharmacy, or a related scientific discipline.
• Minimum of 10 years of progressive clinical operations experience with 7+ years in biotech/pharma/CRO.
• Experience leading Phase I‑IV trials and/or clinical development programs.
• Oncology and/or rare disease experience preferred.
• Significant CRO/vendor management and global trial operations experience.
• Experience in dynamic small biotech environments with small teams is highly desired.
• Prior people management experience preferred.
• Knowledge of ICH‑GCP, FDA/EMA regulations, and global trial requirements.
• Strong risk‑based quality management, inspection readiness, and governance knowledge.
• Excellent project management, communication, and leadership skills.
• Willingness to travel up to 20%.

Responsibilities

• Lead operational planning, execution, and oversight of clinical trials from start-up to closeout.
• Develop timelines, plans, and KPIs; mitigate risks to ensure delivery.
• Drive patient enrollment, retention, and study completion per milestones.
• Lead cross-functional study teams across multiple departments.
• Collaborate with DM/Biostatistics for data quality and reporting.
• Ensure data collection and monitoring per approved plans.
• Review and develop key clinical documents and manuals.
• Manage CROs/vendors, scopes of work, and contracting activities.
• Provide budget governance and change order oversight.
• Monitor budgets, resources, and financial risks; drive efficiencies.
• Maintain quality, compliance, and inspection readiness; support audits.

Skills

Clinical operations

CRO/vendor management

Project management

Leadership

Regulatory knowledge

ICH-GCP knowledge

Budget management

Risk management

Education

Bachelor's degree in Life Sciences or related field

Tools

CTMS

EDC systems

TMF platforms

MS Office

Job description

OnKure Therapeutics in Boulder, CO seeks an Associate Director, Clinical Operations to provide operational leadership for planning and delivering clinical trials across all phases. The role oversees CROs, vendors, budgets, risk mitigation, and inspection readiness, ensuring trials run on time, within budget, and in compliance with GCP and company standards.

You will lead cross‑functional teams, develop study timelines, manage budgets, and drive data quality.