Associate Director of Non-Clinical Safety Evaluation
Competetive salary & benefits package
Our exclusive client is a clinical-stage global biopharmaceutical company based in Cambridge, who are focused on the discovery & development of fully human monoclonal antibody drugs using their proprietary antibody platform which contains a full diversity of human antibodies, making it the most comprehensive antibody development platform in the industry.
They are expanding their pre-clinical development team due to their continued success with groundbreaking projects moving into the clinical stage and are looking for an experienced pre/non-clinical safety leader to manage the company's pre-clinical toxicology programmes.
- Pre-Clinical planning, designing & implementation of multiple projects, across a number of disease areas and the reporting of safety findings & delivery of reg compliant pre-clinical PK/PD & safety studies.
- Establishing external collaborations with contractors/CROs for relevant studies, defining protocols, managing studies, interpreting findings & reviewing reports to established deliverables & objectives
- To be the representative for pre-clinical safety of regulatory documents for IND or CTA submissions
- Establish target safety reviews & risk assessments for novel targets in the support of drug development from hit to lead optimisation & registration
- Design & implement studies to investigate any pre-clinical findings futher
- Keep up-to-date with regulatory guidance & industry standards for pre-clinical GLP studies
- Educated to BSc minimum, with extensive industry experience - ideally to MSc/PhD with relevant industry experience
- Significant industry experience within biopharmaceutical safety testing with a Pharmaceutical company or CRO setting
- Prevous experience of client interaction/CRO interaction
- Excellent communication skills & previous line management experience
- Up-to-date working knowledge of GLP & ICH guidelines to pre-clinical biologics
If however, you do not feel that this is the right role for you, please forward these details on as we do have a generous referral scheme in place.
Please note, due to the high volume of applications, if you do not receive a response within 48 hours, your application has not been successful on this occasion.
Key Terms: Toxicology, toxicologist, project leader, project manager, project director, study director, study manager, study leader, pre-clinical, non-clinical, biopharmaceutical, safety findings, PKPD, PK-PD, PK/PD, pharmacokinetic, pharmacodynamic, CRO, IND, CTA, GLP, ICH, study design, regulatory, safety review, biologics, R&D
- Agency: Clinical Professionals
- Posted: 15th May 2018
- Expires: 12th June 2018
- Reference: JO-1801-366195