Associate Director, Clinical Pharmacology Data Programming Specialist

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, Clinical Pharmacology Data Programming Specialist will provide technical expertise and project leadership for data programming, data management, and quality-control activities supporting clinical pharmacology and pharmacometrics across Genmab’s development portfolio.The role combines hands-on programming with project coordination, including delivery of high-quality analysis-ready data and quantitative outputs, planning timelines, defining programming and QC approaches, and partnering with clinical pharmacologists, pharmacometricians, Clinical Programming, Data Management, Biostatistics, Bioanalytics, Biomarkers, and external vendors.Work arrangement: This role offers flexibility to work away from the office for 20%–40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60-day period, and is approved by the hiring manager.Key ResponsibilitiesPharmacometrics and Clinical Pharmacology Programming· Lead or support programming and QC of analysis-ready datasets and outputs for population PK, exposure-response, PK/PD, NCA, modeling and simulation, immunogenicity, biomarker, and related quantitative analyses.· Develop, maintain, and QC NONMEM-ready and other pharmacometric analysis datasets.· Integrate and pool clinical, dosing, PK, PD, immunogenicity, biomarker, efficacy, safety, laboratory, SDTM, ADaM, and other relevant data across studies.· Develop and maintain programming specifications, derivation rules, analysis datasets, tables, figures, listings, and exploratory outputs.· Provide programming support for data-driven analyses, health-authority requests, publications, conference presentations, and other CPQS deliverables.Programming Quality Control and Validation· Perform independent QC of analysis datasets, derivations, programs, tables, figures, listings, and other quantitative outputs using a developer-reviewer model where appropriate.· Develop validation plans and QC strategies based on the intended use and regulatory importance of the analysis.· Design, test, validate, and document programming logic and reusable analytical workflows, ensuring traceability, reproducibility, and appropriate version control.· Develop automated and reusable data checks and QC tools to improve consistency and efficiency.Project Coordination and Delivery· Plan and coordinate programming activities, milestones, and deliverables across one or more development programs in alignment with project and regulatory timelines.· Work with CPQS scientists to define data and programming requirements and identify risks related to scope, data availability, timelines, or deliverables.· Prioritize requests and support rapid-turnaround and ad hoc analyses when required.· Contribute to resource planning and scalable programming strategies as the CPQS portfolio grows.Regulatory and Submission Support· Provide programming and QC support for clinical pharmacology components of regulatory submissions, including future BLA/sBLA and other global submissions.· Support preparation and QC of datasets, analyses, tables, figures, and supporting documentation for clinical pharmacology reports, Module 2.7.2, and related submission deliverables.· Provide rapid programming support for health-authority requests and other regulatory questions.Standards, Automation, and Innovation· Contribute to CPQS programming standards, templates, libraries, reusable workflows, and automation of routine data preparation, reconciliation, QC, and reporting.· Support development, testing, validation, and maintenance of internal analytical tools, including R/Shiny and other quantitative applications.· Apply modern programming, data-science, and appropriate AI-assisted approaches while maintaining required validation, documentation, and independent QC.· Provide technical guidance and mentoring to colleagues as appropriate.Qualifications· Master’s degree in Statistics, Biostatistics, Computer Science, Mathematics, Engineering, Pharmaceutical Sciences, Life Sciences, or a related quantitative discipline; Bachelor’s degree with substantial relevant experience may also be considered.· A minimum of 3 + years of experience with an advanced degree or 5+ years of experience with a bachelor’s degree of relevant programming experience in biotechnology, pharmaceutical, or related clinical development, with strong experience working with clinical-trial and clinical pharmacology data required.· Experience integrating complex clinical datasets across studies and knowledge of SDTM, ADaM, CDISC standards, and clinical-development data structures is required.· Strong programming skills in R and/or SAS are required; Python experience is desirable.· Experience developing and QC’ing analysis datasets, tables, figures, listings, and regulatory deliverables, with strong understanding of validation, traceability, and reproducibility is required.· Experience supporting population PK, exposure-response, PK/PD, NCA, or related pharmacometric analyses is preferred.· Familiarity with NONMEM, PsN, Phoenix WinNonlin, Monolix, or related pharmacometric software is desirable.· Experience supporting regulatory submissions and health-authority requests is preferred.For US based candidates, the proposed salary band for this position is as follows:$160,400.00---$240,600.00The 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: R17996Profession: Research & Discovery