Associate Director, TMF Operations Lead

Scorpion Therapeutics; United States; Remote; USD 140,000 - 170,000; Full time

Job summary

Scorpion Therapeutics seeks a TMF Operations Lead to develop and execute strategy ensuring TMF completeness, accuracy, and inspection readiness across BBP-418 clinical trials. You will lead TMF operations, establish governance, monitor quality metrics, and manage CRO performance while improving processes for continuous quality enhancement.

The role focuses on ICH-GCP compliance, risk assessment, and support for audit readiness, with potential travel for meetings as needed in a remote work setup.

Qualifications

• 8+ years in TMF, Clinical Operations, or Clinical Quality supporting global trials.
• Strong knowledge of TMF standards, regulatory guidelines, and GxP practices.
• Excellent organizational, communication, and problem-solving skills.

Responsibilities

• Lead TMF operations strategy across all BBP-418 clinical trials to ensure completeness and accuracy.
• Establish governance, monitor quality metrics, and oversee CRO performance.
• Drive inspection readiness activities and support regulatory inspections.

Skills

Organizational skills

Communication skills

Problem solving

Tools

Microsoft Office

SharePoint

Job description

Role

TMF Operations Lead responsible for developing and executing strategy to ensure completeness, accuracy, and inspection readiness of Trial Master Files across all BBP-418 clinical trials. Responsibilities include leading TMF operations, establishing governance, monitoring quality metrics, overseeing CRO performance, and managing inspection preparedness activities. The role involves process improvement, risk assessment, and fostering TMF excellence in compliance with ICH-GCP and regulatory standards, with a focus on audit support and continuous quality enhancement.

Requirements

• minimum 8+ years in TMF, Clinical Operations, or Clinical Quality supporting global trials
• strong knowledge of TMF standards, regulatory guidelines, and GxP practices
• excellent organizational, communication, and problem-solving skills
• proficiency in Microsoft Office tools and familiarity with tools like SharePoint

Preferred

• experience with biologics or small molecules in late-stage development
• regulatory inspection support
• cross-functional collaboration

High-value specifics

• global clinical trial oversight
• inspection readiness
• focus on compliance with ICH-GCP
• supporting the drug development lifecycle
• potential travel for meetings

Work setup

remote with travel expectations