Regional Clinical Study Senior Manager

Scorpion Therapeutics; United States; On-site; USD 150,000 - 190,000; Full time

Job summary

Scorpion Therapeutics is seeking a Regional Clinical Operations Lead to drive study delivery across regional teams in a biopharma setting, with emphasis on oncology indications. You will oversee timelines, budgets, quality, and regulatory readiness, partnering with vendors and sites to ensure compliant execution.

The role requires guiding feasibility through closeout, developing regional tools and SOPs, mentoring staff, and maintaining inspection readiness.

Qualifications

• Minimum 6 years in clinical research with proven team leadership and clinical operations experience.
• Bachelor's in a scientific or healthcare field; a higher degree is preferred.
• Strong knowledge of GxP, ICH/GCP, and clinical trial processes.

Responsibilities

• Lead regional study teams and external vendors.
• Ensure regulatory compliance and inspection readiness.
• Manage planning from feasibility to closeout.
• Oversee site selection, regulatory submissions, data collection and quality assurance.

Skills

Regional leadership

Study management

Oncology focus

Cross-functional collaboration

Inspection readiness

Vendor oversight

Budget oversight

Education

Bachelor's degree

Job description

Role

Regional Clinical Operations Lead responsible for study delivery, quality, timelines, and budget within a biopharma setting, primarily focusing on oncology or cancer indications.

Responsibilities

lead regional study teams and external vendors, ensure regulatory compliance and inspection readiness, manage planning from feasibility to closeout, oversee site selection, regulatory submissions, data collection, and quality assurance; develop regional tools, SOPs, and work instructions; monitor study progress and elevate issues; manage budgets and resources; mentor junior staff.

Requirements

minimum 6 years in clinical research within biotech, pharma, or CRO, with proven team leadership and clinical operations experience; Bachelor's in a scientific or healthcare field (higher degree preferred); experience in clinical research, preferable as CRA; strong knowledge of GxP, ICH/GCP, and clinical trial processes.

HighValue

regional leadership, study management, oncology focus, cross-functional collaboration, inspection readiness, vendor and budget oversight.

WorkSetup

travel may be required, location not specified.