Chief Clinical Operations & Trials Leader

EPM Scientific; San Diego (CA); On-site; USD 250,000 - 350,000; Full time

Job summary

EPM Scientific is seeking a senior Clinical Operations leader to drive programs from start-up through completion and to lead cross-functional teams and CRO partnerships. You will ensure timelines, enrollment, site management, and quality while managing budgets.

The role requires 15–25 years of experience, hands-on trial delivery, and prior leadership in lean biotech or specialty CRO environments, with Phase II–III and registrational exposure within the last 8 years.

Qualifications

• 15-25 years of progressive Clinical Operations experience.
• Hands-on responsibility for trial delivery, not solely executive oversight.
• Experience building, managing, and developing Clinical Operations teams.
• Experience within a lean biotech and/or specialty CRO environment.
• Phase II-III and registrational study execution within the past 8 years.

Responsibilities

• Lead clinical programs from study start-up through completion.
• Drive enrollment, site management, study timelines, and milestone delivery.
• Oversee operational strategy across multiple clinical development programs.
• Direct CRO and vendor oversight.
• Manage critical path activities, risks, and escalations.
• Ensure studies remain on track for quality, timelines, and budget.
• Own program budgets, forecasting, resource planning, and financial management.
• Lead scenario planning and operational strategy development.
• Deliver KPI-driven updates and recommendations to senior leadership.
• Build and improve SOPs, systems, processes, and operational best practices.
• Drive process optimization and organizational scalability.
• Ensure compliance with GCP, regulatory requirements, and inspection readiness.
• Partner closely with Clinical Development, Regulatory, Data Management, Quality, and external stakeholders.
• Support protocol development, study execution, and key development milestones.
• Lead teams through complex operational challenges and decision-making.
• Mentor, coach, and develop Clinical Operations staff.
• Foster a high-performing, accountable, and collaborative team culture.
• Provide leadership within a dynamic, resource-constrained biotech environment.

Skills

15-25 years of progressive Clinical Op

Hands-on trial delivery

Building and developing Clinical Ops 팀

Lean biotech / specialty CRO

Phase II-III execution (last 8 years)

Job description

EPM Scientific is seeking a senior Clinical Operations leader to drive programs from start-up through completion and to lead cross-functional teams and CRO partnerships. You will ensure timelines, enrollment, site management, and quality while managing budgets.

The role requires 15–25 years of experience, hands-on trial delivery, and prior leadership in lean biotech or specialty CRO environments, with Phase II–III and registrational exposure within the last 8 years.