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!OverviewThe Associate Director, Trial Delivery Team Lead plays a key leadership role in overseeing Clinical Trial Managers (CTMs) and Clinical Trial Associates (CTAs) while supporting the broader Clinical Trial Management (CTM) organization. This individual ensures high-quality clinical trial execution by providing strategic guidance, mentorship, and operational oversight. The Line Manager is responsible for team development, resource allocation, process optimization, and ensuring alignment with organizational goals and regulatory standards. The Trial Delivery Team Lead may assume Global Trial Lead (GTL) responsibilities to address fluctuating demands. Roles & ResponsibilitiesLeadership and Line Management:Directly manage, mentor, and develop Clinical Trial Managers (CTMs) and Clinical Trial Associates (CTAs), fostering professional growth.Conduct performance evaluations, provide feedback, and identify training and career development opportunities.Ensure adequate resourcing, workload distribution, and succession planning within the team.Facilitate cross-functional collaboration and knowledge-sharing within the clinical operations team.Collaborate with Global Trial Leads (GTLs) on trial activities for assigned direct reports.Support trial deliverables by facilitating progress, coaching, and mentoring CTMs and CTAs.Advise on resource needs and support overall clinical trial resource planning.Ensure team success through setting clear expectations, guiding performance, and leading competency development.Lead functional working groups; serve as process owner or Subject Matter Expert (SME) within Clinical Operations.Support training initiatives across Trial Operations as needed.Collaborate with senior leadership to define and implement best practices within the Development Operations organization. Process & Compliance Management:Ensure team adherence to Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements (FDA, EMA, etc.).Develop and refine Standard Operating Procedures (SOPs) to optimize trial efficiency and compliance.Support audits, inspections, and regulatory interactions by ensuring inspection readiness across clinical trials.Identify and drive process improvements to enhance trial execution and data quality.Lead cross-trial initiatives as needed, such as implementation of Corrective and Preventive Actions (CAPAs) or new process rollouts across the program.Manages the execution and implementation of CTM and CTA tasks, ensuring operational success.Initiates and supports the development of processes within the CTM and CTA group, focusing on practical application and continuous improvement.Collaborates across functions to drive efficiencies and provide day-to-day guidance to the CTM and CTA groups.Requirements - what you must haveBachelor of science degree with relevant specialization; Master of science degree preferredMinimum requirement of 12 or more years of experience in clinical operationsSignificant experience in leading and managing complex global clinical projects/programsSignificant experience manag
Not specified in the original listing.
Not specified in the original listing.