Our client, a leading clinical stage Biotech, is currently seeking to hire a Toxicologist & Safety Officer. You will be responsible for the design and management of all non-clinical studies to support the preclinical and further development of research and development programs. You will develop the design, preparation and implementation of in vivo and in vitro studies related to all non-clinical development activities to meet regulatory requirements for pre-IND/CTA and IND/CTA submission of biologics and SMEs.
- Design and manage studies in toxicology, ADME, pharmacokinetics and other discipline as they relate to preclinical assessment of safety and efficacy.
- Monitor and coordinate (from initial contract to archiving) outsourced studies to ensure common understanding, compliance with study protocol and regulatory requirements.
- Act as primary contact person to external CROs for the management of out-sourced preclinical studies.
- Interface and provide toxicology guidance to the internal clinical and research groups.
- Write and present non-clinical parts for regulatory submissions.
- 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 in-licensing, acquisitions, and co-development agreements regarding regulatory aspects.
- Cover the Safety aspects as a Safety Officer by identifying potential safety and health hazards, developing prevention proposals, establishing safety documentation and the bases of decision for the management regarding safety (security) and the protection of the health
Skills and Requirements:
- Ph.D. in Toxicology or Pharmacology, Biology or Immunology or alternatively 3-5 years of study director experience in a CRO.
- Strong experience in preclinical development experience in the biotechnology or pharmaceutical industry.
- Supervisory experience in the biotechnology or pharmaceutical industry or a respective CRO.
- Knowledge of GLP regulations, including writing SOPs and study reports.
- Proven ability to meet deadlines.
- Ability to build effective working relationships within the company and with external partners
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Chidozie Orji on +44 207 4400 671 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.