Senior Clinical Operations Leader: Trials & CRO Oversight

Evolving Solution Services; Boulder (CO); On-site; USD 175,000 - 210,000; Full time

Benefits offered by this job

Stock options

Insurance coverage (health)

401(k) plan with company match

Bonus opportunities

Job summary

OnKure seeks an Associate Director, Clinical Operations to provide operational leadership across all clinical development programs. You will oversee trial execution, vendor relationships, and budget management while ensuring compliance with ICH-GCP and regulatory requirements.

You will guide cross-functional teams and drive timelines, risk mitigation, and study reporting. This leadership role supports regulatory submissions and strategic program advancement in a dynamic biotech environment.

Qualifications

• Bachelor's degree or higher in Life Sciences, Nursing, Pharmacy, or related field.
• Minimum of 10 years of progressive clinical operations experience in biotech/pharma/CRO.
• Experience leading Phase I–IV clinical trials and collaborations with CROs/vendor partners.

Responsibilities

• Lead operational planning, execution, and oversight of clinical trials from start-up to closeout.
• Oversee CROs, vendors, and external partners with KPI-driven governance.
• Develop study budgets, accruals, and variance analyses; drive cost optimization.
• Ensure ICH-GCP compliance and inspection readiness across programs.
• Lead cross-functional teams and drive study timelines, milestones, and risk mitigation.

Skills

Leadership

Budget management

Vendor management

Cross-functional collaboration

Regulatory compliance

Education

Bachelor's degree or higher in Life Sciences

Tools

TMF platforms

CTMS

EDC systems

Microsoft Office

Job description

OnKure seeks an Associate Director, Clinical Operations to provide operational leadership across all clinical development programs. You will oversee trial execution, vendor relationships, and budget management while ensuring compliance with ICH-GCP and regulatory requirements.

You will guide cross-functional teams and drive timelines, risk mitigation, and study reporting. This leadership role supports regulatory submissions and strategic program advancement in a dynamic biotech environment.