Principal Scientist Bioanalytics

Principal Scientist Bioanalytics

argenx

Ghent, Belgium

For the expansion of the bioanalytical team, argenx is actively looking for a highly motivated Principal Scientist Bioanalytics with extensive expertise in clinical drug development of large molecules. The candidate will serve as the Bioanalytical (BA) lead and subject matter expert (SME) for one or more argenx compounds and will represent the BA function in (late-stage) clinical development teams. The Principal Scientist will provide direction for bioanalytical strategies (PK/PD and immunogenicity), ensure alignment with global regulatory expectations, and drive the bioanalytical contributions to regulatory plans and submissions in close partnership with internal and external stakeholders.

In addition to excellent communication skills, this position requires demonstrated scientific leadership, deep knowledge of bioanalytical method development and validation (PK/PD and immunogenicity), and strong understanding of global regulatory requirements for late-stage development and registration.

The candidate should have substantial industry experience in bioanalytical sciences, including experience supporting late-stage clinical development and regulatory submissions.

Responsibilities

• Responsible for defining bioanalytical strategies within assigned argenx program(s) and ensuring their operational execution and implementation;
• Engage in expert interactions with partners executing bioanalytical activities for projects (e.g., 3rd party labs), and collaborate with other development functions to achieve program goals (e.g., Global Sample Management, Clinical teams);
• Be a source of and share specific technical expertise within the PharmToxBA group and the assigned project team (e.g., PK/PD and immunogenicity bioanalysis);
• Prepare, review, and contribute to regulatory documentation linked to Bioanalysis; serve as argenx SME in interactions/meetings with regulatory authorities;
• Coach bioanalytical team members and help ensure the team maintains excellent knowledge in specific aspects of bioanalytical methods and relevant regulations;
• Ensure BA-related processes are executed correctly and smoothly; contribute to quality aspects and inspection readiness for internal and outsourced activities.

Profile

• PhD degree in a relevant scientific discipline (or equivalent experience);
• Typically 7+ years of relevant industry experience in bioanalytical sciences (large molecules), including responsibility for bioanalytical activities for clinical programs and support of late-stage development;
• Strong expertise in ligand binding assay platforms; experience with LC-MS for large molecules is a plus;
• Extensive experience in development and validation of PK, PD, or immunogenicity assays for large molecules, with a strong knowledge of applicable global regulatory guidance;
• Demonstrated understanding of GCP/GCLP expectations for bioanalysis of human samples and the ability to ensure inspection readiness across internal and outsourced activities;
• Proven experience leading outsourced bioanalytical work, including 3rd party lab selection, contracting support, governance, and performance management;
• Strong stakeholder management skills; proven experience representing Bioanalytics in clinical development teams and engaging as an expert counterpart with external partners;
• Strong experience preparing and reviewing bioanalytical regulatory documentation and contributing to regulatory plans/submissions; comfortable serving as SME in meetings with regulatory authorities;
• Excellent scientific judgment and problem-solving skills; able to drive resolution of complex, cross-functional issues in a fast-paced environment;
• Strong emphasis on quality, compliance, and data integrity; experienced in ensuring BA-related processes run smoothly and maintaining inspection readiness (internal and outsourced);
• Demonstrated coaching mindset; supports the development of bioanalytical team members and helps sustain strong knowledge of key BA methods and applicable regulations;
• Proactive and flexible, capable of thriving in the dynamic environment of a fast-growing biotech company, with a strategic mindset and a track record of delivery.