We are partnered with a leading Swiss Biopharm to recruit a Principal Scientist - Toxicology/Preclinical Safety on a permanent basis. This is diverse and multi-faceted role, contributing to the evaluation of incoming assets, performing mechanistic studies on toxicology findings, and preparing pre-IND documents. If you have >7 years experience in preclinical safety and are looking for a challenging and scientifically interesting position, check out the below description.
Main areas of responsibility:
?Lead non-clinical safety project teams with multi-disciplinary regional and global members, that develop and execute on the non-clinical safety strategy, provide key inputs and advice into the development of regulatory strategies
?Independently and timely manage high quality non-clinical in vitro and in vivo safety assessment studies or analyses in compliance with all safety, regulatory and GLP requirements in collaboration with internal and/or external stakeholders
?Participate in meetings with regulatory agencies and provide timely and high quality nonclinical input for responding to questions from regulatory authorities
?Drive the key non-clinical input to regulatory documents, including advice meeting packages, CTD modules, Orphan Drug Designations, PIPs, DSURs, Investigator’s Brochures
?Participate in task forces when non-clinical safety expertise is needed
?Build relationships with key contacts, partners and stakeholders internally and externally
?Continue to develop and maintain expertise in the areas of non-clinical safety
?You hold a relevant university degree; preferably a MSc or PhD in Veterinary Medicine, Biology, Chemistry, Biotechnology, or other Life Science area.
?Additionally, at least 5 years of experience in all or most of the main areas of responsibility from the pharmaceutical industry or a CRO testing pharmaceuticals are a key prerequisite to fulfill this position.
?Knowledge/experience working in Oncology, Immunology or Inflammation is desirable
?Knowledge of quality management systems as GLP is important.
?As our company language is English you need to be highly proficient in spoken and written English.
?You are a highly pro-active, enthusiastic and goal-oriented individual with a strong scientific background within the non-clinical safety evaluation of pharmaceuticals, enjoying challenges and working in a friendly collaborative and quickly developing environment.
?As you will be working on several tasks in different projects in parallel, you work in a structured way, have a high quality oriented mindset with the right level of detail, still keeping the overall picture in mind.
?Strong interpersonal skills are necessary, as you will be a major contributor and trusted member of the department.
?The ability to understand your customers’ need and communicate data and recommendations in a professional manner is pivotal