Director, Team Lead Bioanalytical Science

Director, Team Lead Bioanalytical Science
Genmab
Utrecht, Netherlands
€ 97.920 - € 146.880 per year gross
The Role
The Bioanalytical Science team develops bioanalytical strategies to support the pre-clinical and clinical development of Genmab’s formats and compounds. We design, execute, interpret, and validate bioanalytical methods (Pharmacokinetic, Pharmacodynamic and Immunogenicity assays) and perform bioanalysis activities for both regulated (GLP, GCP) and non-regulated studies. As such, we provide a strong foundation for informed decision-making at critical points throughout Genmab’s entire drug development program.
The Team Lead Bioanalytical Study Management is a member of the Bioanalytical Science leadership team and leads the Bioanalytical scientists responsible for study management, scientific oversight, data review, vendor/CRO interactions, and cross-functional Bioanalytical study delivery.
This role combines people leadership and strong Bioanalytical scientific expertise. The Team Lead will provide strategic and scientific leadership for the Study Management function by setting direction for study delivery standards, workload and resource planning, vendor governance, innovation implementation, operational continuity, and role coverage. The successful candidate will be an experienced Bioanalytical professional who can provide scientific credibility, coach and develop scientists, manage priorities across studies and programs, contribute to portfolio prioritization and capability development, and align people, resources, and scientific priorities with Genmab’s R&D portfolio.
Key Accountabilities
Lead, coach, and develop Bioanalytical Study Management scientists as one integrated team, including goal setting, performance enablement, development planning, engagement, role clarity, and accountability for delivery;
Set and drive the strategy for Bioanalytical Study Management, including scientific standards, operating model maturity, delivery expectations, capability development, and alignment with Bioanalytical Science and R&D portfolio priorities;
Contribute as a member of the Bioanalytical Science leadership team to functional strategy, portfolio prioritization, capability investment, resource planning, risk management, and future-state workforce needs;
Provide clear expectations for roles, responsibilities, deliverables, escalation routes, decision-making, and ways of working;
Drive workload, resource, and portfolio planning across studies, programs, vendors, submissions, and key portfolio milestones, including capacity assessment, prioritization, headcount input, sourcing options, budget assumptions, and risk-based trade-offs;
Make and/or recommend risk-based decisions across studies, programs, vendors, and portfolio milestones, balancing scientific quality, timelines, resources, regulatory expectations, and operational risk;
Provide experienced Bioanalytical scientific guidance across study design, assay strategy, data review, scientific interpretation, issue resolution, and key preclinical, clinical, and regulatory documents;
Ensure consistent scientific standards and compliance across Bioanalytical Study Management activities, including applicable GCP/GLP expectations, internal SOPs, documentation quality, data integrity principles, and inspection-readiness requirements;
Support Bioanalytical delivery for clinical and nonclinical studies, including internal activities and outsourced study oversight;
Ensure end-to-end Bioanalytical Study Management oversight from study strategy and planning through delivery, data interpretation, documentation, issue resolution, and close-out;
Act as Bioanalytical Innovation Project Lead; drive the design, execution, interpretation, validation, implementation, and organizational adoption of innovation approaches;
Maintain awareness of relevant scientific literature, regulatory expectations, and technical developments in Bioanalytical Science, and translate applicable advances into improved study management practices, scientific standards, and innovation opportunities;
Oversee vendor/CRO governance, including expectations for communication, timelines, scientific issue resolution, escalation, data quality, performance oversight, and continuous improvement;
Influence and partner effectively with Bioanalytical Science leadership, study scientists, lab colleagues, RAs, QA, regulatory, clinical teams, project teams, senior internal stakeholders, and external vendors to optimize study delivery, quality, and portfolio outcomes;
Identify and manage operational risks related to study coverage, workload pressure, capability gaps, succession depth, knowledge concentration, vendor oversight, and outsourced activities;
Strengthen continuity by ensuring backup coverage, knowledge transfer, and cross-training for critical study management responsibilities;
Lead change with clear communication, stakeholder alignment, role clarity, and active team engagement;
Translate portfolio priorities, regulatory timelines, clinical development needs, and outsourced activities into practical workforce and capability planning actions.
Essential Skills & Experience
PhD in Biochemistry, Biotechnology, Immunology, Pharmaceutical Sciences, Analytical Chemistry, or related discipline with at least 10 years of relevant Bioanalytical experience;
At least 3 years of management experience in a research setting, preferably in a pharma or biotech business context;
Strong experience in Bioanalytical Science, including regulated Bioanalytical study support, assay strategy, data review, scientific interpretation, and issue resolution;
Experience leading and managing Bioanalytical study deliverables across clinical and/or nonclinical development, with accountability for scientific quality, timelines, cross-functional coordination, issue resolution, and continuity of study execution;
Experience supporting internal activities and/or outsourced study oversight;
Strong scientific credibility, with the ability to guide experienced scientists and act as a trusted discussion partner on complex Bioanalytical topics;
Proven people leadership experience, including leading, coaching, developing, and managing scientists and matrixed scientific contributors to ensure study delivery, scientific quality, prioritization across programs, and continuity within the Study Management group;
Experience leading team management processes, including goal setting, development planning, performance enablement, engagement, role clarity, and accountability;
Strong operational judgment, prioritization, and decision-making skills, with the ability to balance scientific quality, timelines, capacity, workload, resources, and risk;
Experience with workload, capacity, resource, and portfolio planning in a scientific or regulated study management environment;
Experience contributing to workforce needs, budget assumptions, capability investment planning, and risk-based prioritization;
Experience with vendor/CRO oversight, including issue escalation, communication, data quality, delivery follow-up, and performance oversight;
Strong understanding of regulatory, GxP, documentation quality, data integrity, SOP, and inspection-readiness expectations, with the ability to apply these principles in Bioanalytical study management, vendor oversight, issue escalation, and delivery of high-quality study outputs;
Experience providing expert Bioanalytical input into preclinical, clinical, and/or regulatory documents within agreed timelines;
Strong cross-functional communication and stakeholder management skills, with the ability to influence Bioanalytical leadership, project teams, QA, regulatory, clinical teams, vendors, senior stakeholders, and external partners;
Ability to identify and manage capability gaps, succession risks, continuity risks, knowledge concentration, and operational dependencies;
Demonstrated ability to lead through change with clear communication, structure, stakeholder alignment, and team engagement;
Experience setting direction for a scientific function, capability area, or study management group, including standards, priorities, operating model, and delivery expectations;
Scientific track record demonstrated through publications, presentations, regulatory contributions, innovation delivery, or recognized subject matter expertise in Bioanalytical Science.
Highly Valuable Skills & Experience
Experience with both LBA and LC-MS/MS environments;
Experience supporting clinical Bioanalytical studies;
Experience with outsourced vendor governance;
Experience preparing Bioanalytical input for submissions or inspections;
Familiarity with GxP expectations, documentation quality, and data integrity principles;
Experience building team structures, decision rights, escalation pathways, and continuity plans during organizational change;
Strong understanding of how Bioanalytical work connects to program milestones, regulatory timelines, clinical development needs, and portfolio priorities.
Apply Now
Don't forget to mention EuroScienceJobs when applying.
Share this Job
More Job Searches
Netherlands
Biochemistry
Biology
Biomedical and Physiology
Chemistry
Commercial
Hybrid
PhD Required
Pharmaceutical
Genmab