If you are inspired by developing your career in a stimulating environment where you can make a profound difference to the healthcare of patients, my client can offer exceptional careers for exceptional people. Based on an established Bioscience campus in Cambridge, you will have the opportunity to work with smarter science, unique technologies and highly experienced scientific leaders.
The company is engaged in the discovery and development of human monoclonal antibody therapeutics using novel monoclonal antibody therapeutic platforms
They are looking to recruit an outstanding 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
Can you see yourself being part of a company that celebrates diversity and believes that better thinking and decisions come from wider experience? If the answer is yes and you have a desire to be an integral part of a dynamic team, we would be keen to hear from you. In the first instance, please send your CV to Matthew Walsh: firstname.lastname@example.org . We endeavour to come back to you within 24 hours of CV submission.
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
- Contact: Edward Thomas
- Reference: JO-1801-366195
- Updated: 30th May 2018
- Expires: 27th June 2018