Ghent Metropolitan Area
Highly motivated, detail-oriented immunology and bioanalytical (GxP) expert with extensive expertise in academia and pharmaceutical industry. In depth understanding of large molecule drug development, experienced in defining and implementing (bioanalytical and biomarker) development strategies to move assets from pre-clinical to late clinical development. Vast experience across multiple therapeutic areas (immunology and neuroscience) and interaction and exposure to EMA / FDA. Authentic, empathic leader with an ability to motivate and empower people. Proven track record of publications in high impact, peer reviewed scientific journals.
Lead a team of biomarker scientists supporting the development of clinical biomarker strategies and responsible for the translation of the exploratory biomarker context of use into the establishment of fit-for-purpose biomarker assays and generation and interpretation of biomarker data. Contribute to the development of a cohesive translational Science team that integrates innovative translational biomarker strategies with advanced translational models (in vitro / ex vivo / in vivo / clinical) with the aim to address scientific questions originating from discovery and clinical development project teams across diverse disease areas.
Established and directed a biomarker team focused on developing and optimizing clinical biomarker strategies, and responsible for implementing biomarker assays aligned with contexts of use, with an emphasis on generating reliable and fit-for-purpose data. Developed a comprehensive framework, including SME roles, clarified R&R and a toolbox, to improve efficiency and consistency.
Responsible to drive the biomarker strategy and implementation of several clinical and preclinical programs within the Immunology therapeutic area, in line with program therapeutic ambition and clinical development plans.
Team Manager • Lead and provide direction to team of bioanalytical scientific managers, project managers and study monitors • Ensure resource and budget to support bioanalytical activities Development Science representative in project teams • Accountable for the design and execution of the Development Science strategy (non-clinical safety, quantitative pharmacology and translational bioanalysis and biomarkers) • Assure strategy is developed, agreed and implemented in line with clinical development plan. Accountable for design and execution of bioanalytical and biomarker strategies • Build bioanalytical strategies in line with pre-clinical and clinical development plans, biomarker strategy plan and clinical pharmacology plan, and ensure bioanalytical input is implemented in these plans • Oversee execution of the bioanalytical strategy internally and through external partners • Accountable for successful development and validation of PK, ADA and biomarker assays, in agreement with FDA/EMEA guidelines • Assure long-term performance of assays and reagent management • Selection and management of bioanalytical CROs (US, Europe and China) • Interpret and communicate bioanalytical data • Act as bioanalytical representative in cross-functional project teams • Establish risk mitigation plans • Participate in writing and reviewing clinical study and regulatory documents (e.g. protocol, ICF, IB, IND, ISI, briefing books etc.) Act as subject matter expert for biomarker strategy, assay validation and data interpretation • Write internal guidance for biomarker assay validation using LBA and IHC • Establish vendor governance with core vendor for IHC activities • Contribute to biomarker strategy and support biomarker activities across different programs • Active contribution to the establishment of an end-to-end process for biomarker strategy design, review and execution.
Project support of pre-clinical and clinical development of lead drug candidates: - In vitro pharmacology testing (mode of action, affinity, specificity, species cross reactivity testing) - GLP-compliant tissue cross reactivity studies - Define bioanalytical strategy in support of PK, POC and Tox studies - Pharmacokinetic and biomarker assay development - Potency assay development, qualification and transfer in agreement with FDA/ EMA guidelines, for drug release and stability testing - Review of study plans/reports and managing timelines of preclinical proof of concept, PK/PD and toxicity studies - Regulatory document writing (e.g. IND, IMPD, scientific advice) Management of bioanalysis team: - Guide scientists in assay development and validation - Responsible for resource planning, timelines and performance management - Representative in multidisciplinary project teams, contributing to project strategy