Bioanalytical Study Lead & Scientific Director

Genmab; Utrecht; On-site; EUR 98,000 - 147,000; Full time

Benefits offered by this job

Pension

Health insurance

Paid time off

Employee support programs

Job summary

Genmab is seeking a Bioanalytical Study Management Team Lead to guide the preclinical and clinical program bioanalysis. You will design, execute, interpret, and validate PK/PD and immunogenicity assays, ensuring high-quality data for decision-making across development.

The role blends people leadership with scientific expertise, driving study delivery standards, resource planning, and跨-functional collaboration with R&D, QA, regulatory, and external partners.

Qualifications

• PhD and 10+ years in Bioanalytical Science with GLP/GCP exposure.
• 3+ years of management experience in a research setting.
• Experience guiding study design, data review and regulatory documents.
• Strong cross-functional collaboration across QA, regulatory, clinical teams.
• Proven ability to lead, coach and develop scientists in a matrix setup.
• Understanding of GxP, data integrity, and inspection-readiness.

Responsibilities

• Lead Bioanalytical Study Management scientists to delivery objectives.
• Set strategy for standards, operating model, and workload planning.
• Oversee vendor/CRO governance and cross-functional study delivery.
• Guide study design, assay strategy, data interpretation and issue resolution.
• Ensure compliance with GCP/GLP, SOPs, and data integrity principles.
• Provide scientific credibility and mentorship to junior scientists.

Skills

Bioanalytical science

Team leadership

Study management

Regulatory knowledge

Education

PhD in Biochemistry, Biotechnology, Immunology, Pharmaceutical Sciences, Analytical Chemistry, or related discipline

Tools

LBA

LC-MS/MS

Job description

Genmab is seeking a Bioanalytical Study Management Team Lead to guide the preclinical and clinical program bioanalysis. You will design, execute, interpret, and validate PK/PD and immunogenicity assays, ensuring high-quality data for decision-making across development.

The role blends people leadership with scientific expertise, driving study delivery standards, resource planning, and跨-functional collaboration with R&D, QA, regulatory, and external partners.