The Role

The 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 Responsibilities

Pharmacometrics 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.
• Relevant programming experience in biotechnology, pharmaceutical, or related clinical development, with strong experience working with clinical-trial and clinical pharmacology data.
• 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---$240,600.00

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

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.