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Drug development and CMC Project-leader - Belgium  

Company managed [?] Still accepting applications
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Posted on : 09 April 2017

Project Description

Your role
  • Developing the pre-clinical development strategy, plans and budget for our programs, with a strong focus on small-molecule CMC 
  • Defining outsourcing projects and selecting/ managing/ reviewing CRO’s for our Phase 1-enabling studies: CMC, formulation development, and GLP tox. 
  • From a development perspective, providing input on the medicinal, pharmacological, toxicological and IP optimization of our small molecule programs, on the patent applications and IP portfolio management, and on compound database management 
  • Reviewing study plans and reports 
  • Reporting directly to our Chief Scientific Officer, and interacting with our scientists and technicians in a multidisciplinary environment 

Your background, skills and attitude
  • Scientist, Ph.D. level willing to explore the unknown 
  • Extensive experience in CMC development of small molecule drugs 
  • Outsourcing and managing skills for Phase 1-enabling CMC and Tox studies in a pharmaceutical R&D environment 
  • Preferably, a strong background in (medicinal) chemistry and affinity with the patenting process would be a plus 
  • Experience in DMPK evaluation and modelling 
  • Excellent communication skills to interact with colleagues, CRO’s and research partners across different disciplines 
  • An entrepreneurial, results oriented, outgoing attitude with a high level of energy; able to work closely in a team; eager to learn 
  • Ability to work effectively in a collaborative and multi-disciplinary team environment where results are achieved through influence and the incorporation of multiple points of view. 
  • Excellent organizational skills, able to multi-task in an environment where priorities might shift as new data comes in 
  • Familiar with MS Word and Excel, SciFinder and ideally also with Dotmatics 
  • Fluent in English, Dutch is a plus