Toxicology Project Director

Recruiter
Clinical Professionals
Location
Cambridgeshire
Salary
£70,000 + Benefits
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Toxicology Project Director
Permanent
Cambridgeshire
£70,000

An established and developing antibody therapeutics company based in Cambridgeshire is expanding their pre-clinical development team due to their continued success and is looking for an experienced pre-clinical toxicology project director to manage the company`s pre-clinical toxicology programmes to develop their biopharmaceutical drug candidates.

Duties/Responsibilities:
- 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

Requirements:
- 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

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