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Associate Director, Trial Delivery Team Lead

$158.72k - $238.08k

Genmab

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 managing/guiding internal (cross-functional) and external (CRO, regulatory authorities) teamsExperience with operational management and budget planningProven performance in earlier role/comparable roleGlobal clinical program level experience requiredExperience within the field of oncology is preferredMinimum 2 years’ experience as Clinical Operations representative in Clinical Development Teams (CDTs) or Global Project Teams (GPTs) would be preferableExperience leading team members in global matrix environment, leveraging tools and technology to ensure business needs are met.Strategic thinking with ability to optimize organizational resources for successful program execution Excellent communication skills in English, both written and spokenMoreover, you meet the following personal requirements:Dedicated team player who enjoys leading teams and inspire trust among colleaguesQuality mindset and able to prioritize your work in a fast paced and changing environmentResult- and goal-oriented and committed to contributing to the overall success of GenmabFor US based candidates, the proposed salary band for this position is as follows:$158,720.00---$238,080.00The 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 contributionsHealth Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insuranceVoluntary Plans: Critical illness, accident, and hospital indemnity insuranceTime Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leaveSupport Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being supportAdditional 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 processAbout GenmabGenmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.Job SummaryJob number: R17959Profession: Development Operations

Vacancy posted 4 days ago
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