Yvette van Bekkum
Senior Consultant Nonclinical Drug Development @ J&S Preclinical Solutions
About
I am an accomplished pharmaceutical nonclinical leader with over 28 years of experience in drug discovery and development. Throughout my career, I have held roles of increasing responsibility in nonclinical safety assessment, most recently serving as Global Vice President of Toxicology & Safety Pharmacology at Johnson & Johnson Innovative Medicine. I bring deep nonclinical expertise across all phases of development—from early discovery through post-marketing—supporting a broad range of therapeutic areas and modalities, including small molecules and biologics. The consultants of J&S Preclinical Solutions support your preclinical drug development programs. At J&S Preclinical Solutions, we pride ourselves in our ability to think outside of the box and to have a problem-solving attitude. Every program is unique, and we like to bring the most appropriate solution for every challenge encountered. J&S Preclinical Solutions has a strong background and experience in assisting small and mid-size (biotech) companies to bring their program to the clinic. We strongly believe that the integration of toxicology and pharmacology readouts early in the development program is an asset that will strengthen and accelerate your drug development. Our experience covers a variety of target indications, such as oncology, autoimmune diseases, CNS, and metabolic disorders. Furthermore, we have experience in small molecules and biologicals, such as therapeutic enzymes, monoclonal antibodies, bispecific antibodies, ADCs, gene therapy and CAR-T cells. J&S Preclinical Solutions is your partner for the following services: • Design and implementation of a fit-for-purpose preclinical drug development plan • Design of preclinical and nonclinical studies - proof of concept, pharmacokinetic, nonclinical toxicology and safety pharmacology studies • Support in organizing preclinical and nonclinical studies and choice of CROs • Monitor outsourced studies • Review of the study reports provided by the CRO • Prediction of safe starting dose in First-In-Human clinical trials • Support MABEL approach and PKPD model development • Evaluation of preclinical dossiers • Writing the nonclinical sections of INDs, IBs, NDAs and BLAs Contact me (yvette@jnspreclinical.com) or my colleagues (info@jnspreclinical.com) to discover how J&S Preclinical Solutions can advance and accelerate your program.
Netherlands
Oss
Pharmaceuticals
Analytical Reasoning, Progressive Thinking, Communication, Scientific Reports, Written Communication, Strategy, Leadership, Line Management, Collaborative Problem Solving, Due diligence, Cross-Cultural Communication Skills, Biotechnology Industry, Cross-functional Collaborations, Collaborative Leadership, Connectivity, Data Integrity, Ethical Leadership, Resiliency, Flexible Approach, Analytical Skills
Experience

Reflecting, reorienting and recharging
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Vice President, Global Head Toxicology & Safety Pharmacology
Beerse, Belgium
• Led a global team in EU, US, China and Japan of approximately 100 scientific and operational professionals across project toxicology, safety pharmacology, various toxicology disciplines, nonclinical outsourcing and submissions • Developed and implemented innovative nonclinical study designs and strategies, optimizing speed, cost, quality, and adherence to 3Rs principles and international regulatory guidelines. • Reviewed nonclinical regulatory submission documents across the entire J&JIM portfolio, encompassing a broad spectrum of synthetic and biologic compounds. • Led organizational and operational transformations in collaboration with cross-functional teams, a.o. successfully reducing cycle times and costs. • Spearheaded nonclinical innovation initiatives, including advancements in 3Rs methodologies, data sciences and the integration of AI/ML in drug development. • Built a community with focus on engagement, enterprise mindset, learning and development.

Senior Director, interim Global Head Nonclinical Safety
Beerse, Belgium
• Developed organizational and scientific strategies for moving from regional to global organizational orientation, as well as from modality specific to modality agnostic organization. Modalities include small molecules, peptides, vaccines, RNA therapeutics, antibodies, cell- and gene therapy. • First in Human committee member representing Nonclinical Safety.

Senior Director, EU Head In Vivo Sciences and Toxicology & Global Head Toxicology Outsourcing
Beerse, Belgium
• Responsible for in vivo toxicology studies from study design to integrated study reporting - including study directors/monitors, biotechnicians, formulations unit. • Member of GLP Test Facility Management, successfully passing all inspections (OECD GLP, AAALAC EHS&S). • Led the phase-out of GLP activities and redefined the outsourcing strategy. • Initiator and sponsor of several global data sciences projects.

Head Project Toxicology and Planning
Schaijk, the Netherlands
• Global integration coordinator following the merger of Organon and Schering-Plough. • Led project toxicologists of all legacy-Organon (~ 50) compounds in various therapeutic areas and phases of preclinical development, for toxicology and DMPK.

Head Project Toxicology and Outsourcing
Schaijk, the Netherlands
• Responsible for project toxicologists, outsourcing coordinators and planners in the Netherlands and France. • Project Toxicologist for multiple projects (Neuroscience, Womens' Health), learning drug discovery and development in multifunctional teams • Developed and implemented outsourcing strategy
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