Inspection Readiness Leader, Clinical Operations

Genmab; Princeton (NJ); On-site; USD 156,000 - 234,000; Full time

Benefits offered by this job

401(k) match

Health benefits

Voluntary insurance

Paid time off

Parental leave

Wellness resources

Commuter benefits

Tuition reimbursement

Lifestyle Spending Account

Job summary

Genmab is seeking an Associate Director, Inspection Readiness to lead and maintain high compliance across clinical trials and with service providers. You will design frameworks, drive GCP inspection readiness, and mentor teams within Clinical Trial Operations.

The role requires MSc level in Life Sciences or related field, 10+ years in clinical operations/quality, and strong regulatory acumen across FDA, EMA, MHRA, and ICH-GCP standards.

Qualifications

• Master’s degree in Life Sciences, Pharmacy, Medicine or related discipline.
• 10+ years in Clinical Operations, Clinical Quality, Inspection Readiness or Clinical Compliance.
• Strong understanding of clinical trial processes, ICH-GCP & regulations.
• Project management skills and knowledge of tools and processes.
• Identify risks, develop mitigation strategies, resolve issues.
• Experience creating efficient systems and processes.
• Strong stakeholder management across a global matrix.
• Experience mentoring colleagues and providing guidance.
• Excellent written and verbal communication skills.

Responsibilities

• Establish an inspection readiness framework for Clinical Trial Teams across trial lifecycle.
• Design tools and processes for trial inspection readiness with digitalization and automation.
• Provide strategic guidance for investigations of non-compliances and quality events.
• Lead continuous assessment of inspection readiness using key metrics.
• Develop and deliver GCP inspection readiness training/tools for stakeholders.
• Collaborate with GCP QA and support inspection setup during inspections.
• Act as Inspection Control Room Lead during GCP inspections.
• Develop lessons learned from inspection readiness outcomes within Clinical Trial Operations.
• Drive audit findings trend analysis and cross-program risk assessments.

Skills

Clinical Operations

ICH-GCP knowledge

Regulatory compliance

Project management

Stakeholder management

Mentoring

Communication skills

Education

Master's degree in Life Sciences / Pharmacy / Medicine

Job description

Genmab is seeking an Associate Director, Inspection Readiness to lead and maintain high compliance across clinical trials and with service providers. You will design frameworks, drive GCP inspection readiness, and mentor teams within Clinical Trial Operations.

The role requires MSc level in Life Sciences or related field, 10+ years in clinical operations/quality, and strong regulatory acumen across FDA, EMA, MHRA, and ICH-GCP standards.