The RoleThe Associate Director, Inspection Readiness plays a key role in supporting the Clinical Trial Operations organization by contributing to building clinical compliance and inspection readiness throughout the clinical trial teams and with service providers. This position is essential for leading, building and maintaining high compliance standards across trials and Genmab portfolio. This individual will additionally lead improvements of core processes.
ResponsibilitiesTrial Inspection Readiness and Preparation- Establishing and maintaining a sustainable inspection readiness framework for the Clinical Trial Teams to work from across the life cycle of a trial
- Design and optimize tools and processes for trial inspection readiness, leveraging digitalization and automation to improve efficiency and compliance.
- Provide strategic guidance and subject matter expertise for investigations of potential non-compliances, including in relation to GCP serious breaches or other non/reportable persistent non-compliance events, quality events - follow-up and closure, contributing to increased sponsor oversight.
- Drive continuous assessments of compound and/or trial inspection readiness by analysing key metrics to interpret and generate actionable insights.
- Lead the development and delivery of GCP inspection readiness training/tools for Clinical Trial Operations and other key stakeholders.
- Collaborate closely with GCP QA and support the operational framework and inspection setup during sponsor and site/vendor GCP inspections.
- Act as Inspection Control Room Lead during GCP inspections.
- Develop and conduct lessons learned from inspection readiness, preparations and outcomes within Clinical Trial Operations.
Quality Events Oversight - Drive audit and inspection learnings and risk assessments cross-trial, cross-program and evaluate the organizational impact.
- Maintain oversight and drive compliance of Clinical Trial Delivery quality events and effectiveness checks.
- Completes trending of findings from audits, inspections and Quality Events as relevant for roles within Clinical Trial Operations and other key stakeholders.
Clinical Compliance - Lead continuous improvements of core processes, prioritizing high-risk routinely inspected areas within Clinical Trial Operations
- Collaborate cross-functionally to align clinical compliance and inspection readiness with broader development strategies.
- Provide support related to ICH-GCP, regulatory requirements (e.g. FDA, EMA, MHRA, PMDA, NMPA) and Genmab SOPs.
- Lead and contribute in functional and/or cross-functional business processes or system enhancement/innovative initiatives.
Requirements- Master's (MSc) degree in Life Sciences, Pharmacy, Medicine or a related discipline.
- Minimum of +10 years of experience in Clinical Operations, Clinical Quality, Inspection Readiness or Clinical Compliance role within the pharmaceutical or biotechnology industry.
- Strong understanding of clinical trial processes, ICH-GCP & regulations, and the clinical drug development lifecycle.
- Project management skills and knowledge of tools and processes.
- Ability to proactively identify risks, develop mitigation strategies, and effectively resolve issues.
- Experience in creating systems and processes for efficiency and effectiveness.
- Strong stakeholder management skills with the ability to collaborate effectively across functions working in a complex, global, and matrix organization.
- Experience mentoring and supporting the development of colleagues.
- Excellent written and verbal communication skills.
For US based candidates, the proposed salary band for this position is as follows:
$156,000.00---$234,000.00
The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.
When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:
- 401(k) Plan: 100% match on the first 6% of contributions
- Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
- Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
- Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
- Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
- Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses
Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process
