Global Head of Clinical Process & Standards

Galderma S.A.; Boston (MA); On-site; USD 200,000 - 265,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) with employer match

Paid time off

Job summary

Galderma S.A. in Boston is seeking a seasoned Head of Clinical Process and Standards to lead global CTAs and oversee critical TMF, SOPs, and training programs. You will align clinical processes with ICH/GCP and regulatory standards while partnering with quality to ensure inspection readiness.

You will drive system maintenance for TMF/CTMS, develop standard documents, and implement scalable training tools, enabling efficient, compliant trial execution across the portfolio.

Qualifications

• 15+ years of progressive experience in clinical operations
• Minimum 5 years in a managerial role in Pharma/Biotech or CRO
• Systemic drug and biologics experience preferred
• Excellent knowledge of ICH/GCP, GMP/GDP
• Strong understanding of the product development process and CTMS/eTMF

Responsibilities

• Lead a global team of CTAs supporting clinical trials
• Oversee TMF inspection readiness for all studies
• Develop and implement strategies for clinical trial operations
• Maintain and improve CTMS and eTMF systems
• Drive process development, training, and standardization across study teams
• Collaborate with quality to ensure inspection readiness and CAPA responsiveness

Skills

Leadership

Clinical Operations

Project Management

CTMS

eTMF

GCP/ICH Knowledge

Regulatory Inspection Readiness

Education

Bachelor’s degree in Life Sciences or related field

Tools

CTMS

eTMF

Job description

Galderma S.A. in Boston is seeking a seasoned Head of Clinical Process and Standards to lead global CTAs and oversee critical TMF, SOPs, and training programs. You will align clinical processes with ICH/GCP and regulatory standards while partnering with quality to ensure inspection readiness.

You will drive system maintenance for TMF/CTMS, develop standard documents, and implement scalable training tools, enabling efficient, compliant trial execution across the portfolio.