Internationally recognized immunology, immunogenicity and bioanalytical expert with 15+ years across biologics, vaccines, gene & cell therapies and advanced drug delivery, spanning preclinical to clinical readiness
Proven leader in preclinical-to-clinical translation, defining tox, PK, proof-of-concept, biomarker and immunogenicity strategies, with deep hands-on expertise in LBA and cellbased ADA assays
Highly experienced in regulatory strategy and direct FDA/EMA engagement, guiding programs through IND/clinical readiness while ensuring alignment with GMP/GLP/GCP and robust potency and release approaches
Trusted advisor and board-level contributor managing CRO/CMO/vendor ecosystems, leading due diligence and innovation evaluations, and delivering executive-level training consistently rated among top lecturers
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Overview
- Availability
- Asap; full-time; remote & on-site
- Qualification
- PhD in Immunology
- Language Skills
- English (business fluent), German (fluent), Dutch (fluent)
- Relevant Expertise
- (Pre) Clinical Drug Development, Immunogenicity, Immunology, Bioanalysis, ADA Assays (LBA), Cell-based Assays, Translational Development, Preclinical Development, Regulatory Strategy (FDA/EMA), GMP/GLP/GCP, CRO/CMO Management
Key-Facts
Extract from Previous Activities
Associate Partner
Lead and advise on preclinical, translational, and bioanalytical strategies
Support client programs from early development through clinical readiness
Complement commercial teams with deep scientific and regulatory expertise
External Evaluator
Evaluate and rate innovative business plans in next-generation biologicals
Contributed to successful seed funding decisions for early-stage biotech companies
Consultant Trainer
Deliver global training courses in biopharmaceutical development
Consistently ranked among top lecturers based on participant numbers and evaluations
Interim Director of Biology
Led mode-of-action studies for a silica nanoparticle nucleic-acid delivery platform
Provided scientific leadership supporting first-in-human readiness
Interim Director of Vaccines
Led manufacturing and regulatory approval strategy for plasmid-based vaccine candidates
Guided development of disruptive vaccine technologies for livestock
Subject Matter Expert, Bioanalysis
Defined clinical bioanalytical and immunogenicity strategies
Led immunogenicity risk assessments and vendor oversight
Supported development of a novel monoclonal antibody
External Expert
Resolved regulatory and bioanalytical challenges for multiple clients
Supported transition from late preclinical to first-in-human across drug classes
Interim Head of R&D & Preclinical Development
Built and led R&D teams
Drove proof-of-concept studies and IND preparation
Managed CRO/CMO outsourcing and innovation risk strategy