3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg and Oss. We are dedicated to the development of (bio-) pharmaceuticals and diagnostics. Our team of experts covers the key areas of pre-clinical, clinical, CMC, regulatory affairs and project management. In addition, we provide out-licensing and interim management support. Our clients are leading big pharma companies as well as innovative biotech start-ups.
Consultant Non-Clinical Development
For the various projects that we are running for our clients, we are looking for a consultant non-clinical development to join our team of consultants. The ideal candidate has a background in ADME (preferred) and Toxicology and is able to look beyond his or her borders and has an ambition to grow in a young and growing organization. Training and/or coaching will be provided in specific areas if needed.
- PhD or equivalent, or MSc degree in Life Sciences, with experience in drug development orsimilar field
- At least 3 years of experience as an ADME study director, non-clinical project manager orother drug development role
- Communication skills: good oral, writing and presentation skills
- Personality skills: pro-active, team player, results-oriented, can-do mentality and ability to putyourself in the position of our clients
- Experience in a number of the following areas and roles (not all required):
- Experience in conducting or monitoring drug metabolism studies
- Experience in designing, monitoring or conducting safety (toxicology) studies at CRO’s andanalyzing/presenting data
- Knowledge of and experience in global regulatory requirements for the development andregistration of new medicinal products (chemical entities and/or biologicals)
- Experience in drafting and reviewing biocompatibility and/or safety assessments,researching literature and toxicology database resources, and summarizing information
- Experience in writing and/or reviewing documents for specific global regulatory purposes,e.g. investigators’ brochures, IMPD, (non-)clinical dossier (eCTD), etc.
- Understanding of Good Laboratory Practice (GLP) regulations
- Project coordination and project team participation
Please attach your CV to our contact form!