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
Solliciteren