Head Of Nonclinical Safety

Head of Nonclinical Safety Our client, a young Biotech company with an exciting pipeline, now have approval for a Nonclinical Expert role within their growing Clinical Science team. As a nonclinical expert you will be accountable for the design of the company’s nonclinical safety and toxicology studies and implementation of planned studies with partner CRO’s while meeting standards of excellence for ethics, scientific merit and regulatory compliance. This hire will be the interface with health authorities acting as the company toxicology representative and addresses questions in interactions with FDA, EMA and other authorities on nonclinical safety topics. Responsibilities include: Responsible for developing nonclinical safety strategies that support the clinical development plan. Responsible for selecting appropriate nonclinical CROs, proposal reviews and budget management. Responsible for planning and developing study designs, outsourcing partner management/consultants, oversight of operational activities, results reporting and review of analysis and interpretation. Consolidating safety data from nonclinical studies into key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers. Interacting and seeking input from external partners/experts. Requirements include: PhD or equivalent degree in the areas Toxicology or Pharmacology, with 10+ years related experience. Professional toxicological registration, ERT or DABT is preferable. Experience of toxicological risk assessment of impurities, extractables and leachables is beneficial but not essential. Demonstrates a broad knowledge in field of pharmaceutical toxicology and possesses knowledge of the relevant regulatory guidelines and preparation of submission documentation. Experience with NDA and MAA submissions is advantageous. Demonstrates good medical / scientific writing skills. Experience in working and influencing cross-functionally. Exhibits high motivation and high energy level, self-starter. For further details, please contact Larry on +353 1 – 2302400 / larry@rftgroup.ie The RFT Group , BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie Follow us on Twitter, Facebook and LinkedIn