Global Head of Clinical Process & Standards

Galderma Research & Development, LLC; Boston (MA); On-site; USD 200,000 - 265,000; Full time

Job summary

Galderma Research & Development, LLC in the United States seeks a Head of Clinical Process and Standards to oversee TMF, clinical systems, and SOP governance within Clinical Operations, ensuring GCP compliance and inspection readiness.

You will lead a global team of CTAs, drive process improvements, and collaborate with QA, IT, and portfolio leaders to support regulatory inspections and digital transformation.

Qualifications

• Bachelor's degree required in Life Sciences or related field.
• Minimum 15 years progressive clinical operations experience, with at least 5 years in a managerial role.
• Strong knowledge of ICH/GCP and applicable local regulations.

Responsibilities

• Lead a global team of CTAs responsible for operational tasks supporting clinical trials.
• Develop and implement strategies for clinical trial operations to meet organizational goals.
• Oversee maintenance and improvements of CTMS and other clinical systems.
• Ensure TMF remains inspection ready and compliant with GCP.
• Collaborate with IT to translate departmental needs into timely system improvements.
• Develop and oversee training content in PATH and study-level training tools.
• Establish and maintain a clinical systems roadmap aligned with portfolio growth.
• Foster a culture of inspection readiness and continuous process optimization.

Skills

Leadership

ICH/GCP knowledge

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences or related field

Tools

CTMS

eTMF

Job description

Galderma Research & Development, LLC in the United States seeks a Head of Clinical Process and Standards to oversee TMF, clinical systems, and SOP governance within Clinical Operations, ensuring GCP compliance and inspection readiness.

You will lead a global team of CTAs, drive process improvements, and collaborate with QA, IT, and portfolio leaders to support regulatory inspections and digital transformation.