Associate Director, Clinical Operations

Scorpion Therapeutics; Miami (FL); On-site; USD 170,000 - 210,000; Full time

Job summary

Scorpion Therapeutics seeks an Associate Director of Clinical Operations to lead global oncology Phase 2/3 trials, including NSCLC and CRC, with a strong focus on execution and vendor management.

You will oversee trial planning, ensure GCP/ICH compliance, manage CROs, control budgets, and maintain inspection readiness while driving cross-functional collaboration with Regulatory, Clinical Science, Data Management, and Quality teams. Travel up to 20% is expected.

Qualifications

• 10+ years of experience managing international oncology clinical trials.
• Strong leadership, regulatory and operational expertise.
• Experience overseeing CROs and external vendors.

Responsibilities

• Oversee clinical trial planning and execution for global oncology trials.
• Ensure compliance with GCP/ICH guidelines and regulatory requirements.
• Manage CROs and external vendors, including vendor selection and performance monitoring.
• Mitigate operational risks and control trial budgets.
• Maintain inspection readiness and TMF quality across studies.
• Foster cross-functional collaboration with Regulatory, Clinical Science, Data Management, and Quality teams.
• Lead development and approval of study plans and TMF artifacts.
• Drive process improvements in Clinical Operations.

Skills

Leadership

Regulatory expertise

Operational management

Budget management

Vendor management

GCP/ICH compliance

Cross-functional collaboration

Education

Bachelor's degree in life sciences or related field

Job description

Role

Associate Director, Clinical Operations leading global oncology Phase 2/3 trials, including NSCLC and CRC indications, with a focus on operational execution and vendor management.

Responsibilities

• oversee clinical trial planning
• ensuring compliance with GCP/ICH
• manage CROs and external vendors
• mitigate operational risks
• control budgets
• maintain inspection readiness
• foster cross-functional collaboration across Regulatory, Clinical Science, Data Management, and Quality teams
• Lead the development and approval of study plans
• manage TMF quality
• drive process improvements

Qualifications

• Bachelor's degree in life sciences or related field; 10+ years of experience managing international oncology clinical trials, with strong leadership, regulatory, and operational expertise.

Preferred

• deep knowledge of drug development, GCP/ICH, and complex global study execution.

High-Value

• Oncology (NSCLC, CRC), Phase 2/3, international, vendor oversight, inspection readiness, cross-functional leadership.

Work Setup

not specified; travel up to 20%.