Senior Clinical Biomarker Manager

Plays a critical role in advancing precision medicine and therapeutic development by identifying and validating biomarkers for use in clinical trials, disease diagnostics, prognosis, and treatment selection.

What will you do?

• Lead efforts to identify and validate disease-specific biomarkers that have clinical utility and operational feasibility;
• Participate in monitoring the competitive landscape in terms of efficacy levels in indications of interest;
• Collaborate with disease experts, clinical researchers, and laboratory teams to develop and execute biomarker discovery strategies tailored to specific fibrotic diseases and regenerative medicine;
• Contribute to the design of biomarker-driven endpoints, patient selection criteria, and monitoring strategies to enhance the clinical trials efficacy and patient stratification;
• Work closely with clinical operations teams to integrate validated biomarkers into clinical trial protocols;
• Identify and manage specialized laboratories, including sample handling/storage/shipment and data transfer agreements. Monitor and track of data generated during clinical execution;
• Analyze biomarker data to derive actionable insights. In close collaboration with statistics, assess the significance of biomarker findings, correlate with clinical outcomes, and provide recommendations for further investigation or clinical application;
• Collaborate with cross-functional teams, including translational leads, clinicians, trial managers, bioinformaticians, and regulatory experts, to ensure the successful implementation of disease-related biomarkers in clinical studies;
• Lead the validation and qualification of disease-specific biomarker assays, ensuring they meet regulatory and quality standards;
• Establish and maintain standard operating procedures (SOPs) for biomarker testing in a clinical setting;
• Ensure adherence to relevant regulatory requirements, such as Good Clinical Laboratory Practice (GCLP) and Good Clinical Practice (GCP), when implementing biomarker assays in clinical studies. Support regulatory submissions and interactions with authorities as needed;
• Effectively communicate biomarker strategies, results, and implications to internal stakeholders, external collaborators, and regulatory bodies;
• Prepare scientific presentations, contribute to publications, and participate in scientific forums relevant to disease-specific biomarkers.

Who are you?

• Master, PharmD, PhD or MD degree in the scientific, medical or paramedical area;
• Experience 8+ years in disease related biomarker discovery, validation, and clinical implementation;
• Strong clinical focus, with a deep understanding of disease biology, patient care pathways, and clinical trial methodologies;
• Detailed oriented mindset, strong problem-solving skills, excellent team player, and strong communications skills
• Knowledge of fibrosis, immunology, inflammation, or related therapeutic areas is an advantage.
• Experience with imaging biomarkers is a plus.

What we offer

• A unique opportunity to shape Clinical Pharmacology in an ambitious, innovation-driven biotech company.
• The chance to contribute directly to pioneering therapies addressing unmet medical needs.
• A collaborative, excellence-focused team environment with room for personal and professional growth.
• Flexible working arrangements with the option to work three days per week from home (role based in Antwerp).
• Competitive compensation and benefits.
• A fast-paced, agile, and empowering work environment.

Agomab is a young and dynamic biotech company developing medicine for patients with inflammatory and fibrotic diseases, including Crohn's disease.