Overview

At Genmab, we are dedicated to building extra not ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.Does this inspire you and feel like a fit? Then we would love to have you join us!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 PreparationEstablishing and maintaining a sustainable inspection readiness framework for the Clinical Trial Teams to work from across the life cycle of a trialDesign 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. RequirementsMaster's (MSc) degree in Life Sciences, Pharmacy, Medicine or a related discipline.Minimum of 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 processe