Head of bioanalytical study management Vacatures

Over de vacature

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