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Director, Team Lead Bioanalytical Science


Overview

In this role you lead the Bioanalytical Study Management team, shaping strategy and ensuring high-quality study delivery across clinical and nonclinical programs. You provide scientific credibility, coach scientists, and align resources with the R&D portfolio. You drive risk-based decisions and maintain regulatory and data integrity standards. Joining Genmab means contributing to transformative antibody medicines and multidisciplinary collaboration that accelerates cancer and disease therapies.

Arbeidsvoorwaarden / Benefits
  • Pension
  • Health insurance and wellness benefits
  • Paid time off
  • Employee support programs
Verantwoordelijkheden
  • Lead and develop Bioanalytical Study Management scientists as a cohesive team with clear goals and accountability
  • Set strategy for study management, including standards, operating model, and capability development
  • Contribute to leadership decisions on portfolio priorities, resource planning, and risk management
  • Define expectations for roles, deliverables, escalation routes, and ways of working
  • Oversee workload, capacity, vendor interactions, and budget assumptions across studies and programs
  • Provide scientific guidance on study design, assay strategy, data review, and issue resolution
  • Ensure compliance with GCP/GLP, SOPs, data integrity, and inspection readiness
  • Support clinical and nonclinical study delivery and oversee outsourced activities
  • Lead innovation in bioanalytical study management and translate literature/regulatory advances into practice
  • Manage vendor/CRO governance, communication, timelines, and data quality
  • Influence cross-functional teams to optimize study delivery and portfolio outcomes
  • Identify and mitigate operational risks and ensure continuity and cross-training
  • Lead change with clear communication and stakeholder alignment
  • Translate portfolio priorities into practical workforce and capability plans
  • Oversee end-to-end study management from strategy to close-out
Belangrijkste vereisten
  • PhD with at least 10 years of bioanalytical experience
  • At least 3 years of management experience in a research setting (pharma/biotech preferred)
  • Strong track record in regulated bioanalytical study support, assay strategy, data review, and issue resolution
  • Experience leading study deliverables across clinical/nonclinical development with emphasis on quality and timelines
  • Proven ability to guide scientists and serve as a trusted expert on Bioanalytical topics
  • Demonstrated leadership in coaching and developing scientists within a matrix organization
  • Experience with workload, capacity, resource, and portfolio planning in a scientific environment
  • Experience with vendor/CRO oversight, escalation, and data quality management
  • Solid understanding of regulatory GxP, documentation quality, data integrity, SOPs, and inspection readiness
  • Ability to contribute to regulatory documents and interact with QA/regulatory teams
  • Strong cross-functional communication and stakeholder management skills
  • Capacity to identify capability gaps, succession risks, and operational dependencies
  • Proven ability to lead through change with clear communication and engagement
  • Experience setting direction for a scientific function or study management group
  • Scientific track record in Bioanalytical Science (publications, regulatory contributions, or recognized expertise)
  • Knowledge of both LBA and LC-MS/MS environments (preferred)
  • leadership and coaching
  • strategic thinking
  • cross-functional collaboration
  • Bioanalytical science including regulated study support
  • assay strategy and data interpretation
  • GLP/GCP knowledge

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