Proclinical has partnered with a pharmaceutical company in search for a Principal toxicologist with strong expertise in non-clinical safety to support candidate selection and preclinical development of small molecules and biologics. Main focus will be the direct supervision of toxicology and safety pharmacology studies as well as the supervision of a in vitro safety scientist.
- Set the overall strategy for toxicology programs for the various projects at ACI in consultation with Senior Management
- Design, implement and manage toxicology and non-clinical safety pharmacology studies
- Supervise the analysis and data interpretation of in vitro safety studies
- Recommend and manage selected CRO relationships including the coordination of (from initial contract to archiving) outsourced studies to ensure accurately reporting of results, compliance with study protocol and regulatory requirements.
- Provide interpretation of the data and toxicology guidance to the internal clinical, regulatory and research groups.
- Take responsibility for the writing of the non-clinical safety and toxicology sections of regulatory documents and interactions with health authorities.
- Review of scientific literature relevant to preclinical product development.
- Ensure compliances with GLP regulations in designing protocols, analyzing and interpreting the data and preparing relevant documentation.
- Support the business development team on technical due diligence associated with out-licensing, and co-development agreements regarding non-clinical safety aspects.
- Complete activities in a timely manner that allow a project to achieve deliverables and milestones
- Provide toxicology and non-clinical safety expertise as a project team member
Skills and Requirements
- Ph.D. in Toxicology or Pharmacology, Biology or Immunology or alternatively 3-5 years of study director experience in a CRO
- At least 5-7 years of non-clinical safety experience in the biotechnology or pharmaceutical industry and track record of interacting with regulatory agencies
- Supervisory experience in the biotechnology or pharmaceutical industry or a respective CRO
- Current with GLP regulations and experience in writing SOPs and study reports
- Leadership and project management skills
- Have excellent interpersonal, analytical and communication skills as well as fluent in speaking and writing in English
- Able to build effective working relationships within the company and with external partners as a team player
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.