Vice President, Clinical Compliance and Systems

Scorpion Therapeutics; United States; Hybrid; USD 300,000 - 420,000; Full time

Job summary

Scorpion Therapeutics is seeking a Strategic Vice President, Clinical Compliance & Systems to lead compliance governance within Clinical Operations. You will shape the vision for TMF, eTMF, CTMS, and related systems, ensuring inspection readiness and scalable clinical trial operations.

You will build and mentor high-performing teams, drive global regulatory adherence (ICH-GCP, ICH E6(R3)), and partner with Quality, IT, and Development Sciences to deliver innovative, compliant clinical solutions

Qualifications

• Bachelor's degree in science, healthcare, or related field.
• 15+ years in Clinical Ops, Quality, or Systems within pharma/biotech.
• Proven leadership in building and developing teams; regulatory expertise.

Responsibilities

• Establish strategic vision and mentor high-performing teams in clinical compliance operations.
• Oversee global regulatory compliance with ICH-GCP and ICH E6(R3).
• Modernize clinical processes and technology platforms (eTMF, CTMS) and drive lifecycle management.
• Collaborate across Quality, IT, and Development Sciences to ensure scalable operations.

Skills

Leadership

Strategic thinking

Influencing skills

Cross-functional collaboration

Education

Bachelor's degree in science/healthcare or related field

Tools

eTMF

CTMS

Job description

Role: Strategic Vice President, Clinical Compliance & Systems within Clinical Operations, leading the development of compliance, inspection readiness, TMF governance, and clinical systems infrastructure.

Responsibilities

establish strategic vision, build and mentor high-performing teams, oversee clinical compliance activities in line with global regulations (ICH-GCP, ICH E6(R3)), and modernize clinical processes and technology platforms (eTMF, CTMS). Collaborate across functions including Quality, IT, and Development Sciences to ensure scalable, compliant, and innovative clinical trial operations. Develop and execute roadmaps for clinical systems, oversee system selection, integration, validation, and lifecycle management, and evaluate emerging digital technologies. Drive operational excellence through metrics, dashboards, and continuous improvement initiatives.

Qualifications

Bachelor's degree in science, healthcare, or related field; 15+ years in Clinical Ops, Quality, or Systems within pharma/biotech; proven leadership in building and developing teams; deep knowledge of global clinical trial regulations and systems; strategic thinker with strong influencing skills; experience operating in fast-paced, innovative environments.

High-Value: focus on clinical development, compliance, and systems infrastructure for a growing biotech portfolio, including post-bariatric hypoglycemia, Wolfram syndrome, and ALS, with remote work flexibility and periodic travel to Cambridge, MA.