Director Toxicology & Non-Clinical Safety Project Director

Hobson Prior are looking for an Senior Director Toxicology & Non-Clinical Safety Project Director to join a clinical-stage biotechnology organisation in Cambridge on a permanent basis. Our client is focused on developing medicines for patients with neurologic diseases.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• In this role you will act as the project team representative for non-clinical safety on multidisciplinary project teams.
• You will develop overall toxicology strategy and plans to support the clinical development plan.
• Oversee outsourced preclinical toxicology studies at multiple external Contract Research Organizations.
• Select appropriate CROs.
• You will collaborate with others on the development team, design the strategy for assessing non-clinical safety for development candidates, including giving strategic advice on timings.
• Design & execute investigative toxicology studies, based upon off & on-target safety profiles of the candidate drugs.
• You will manage toxicology studies for appropriate conduct, accuracy, and timely execution.
• Audit raw data for accuracy, review and finalize reports in partnership with CROs as submission-ready documents for regulatory authorities.
• Proactively respond to study issues and resolve problems with study director.
• Internal and external communication.
• Prepare verbal and written summaries for internal discussions.
• You will review and author toxicology and safety pharmacology sections of various regulatory documents and ensure their regulatory compliance.
• You will represent company at meetings with regulatory agencies.

Requirements:

• Educated in a BSc or equivalent in toxicology, pharmacology, or a related field.
• Excellent knowledge of toxicology and toxicologic pathology with experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies.
• Experience in supporting project teams as toxicology representative.
• Significant experience in toxicology small molecule drug development in Biotech/Pharma industry.
• Experience in filing multiple INDs.
• Proven ability to communicate well within a multifunctional drug development team, with excellent oral and written communication skills.
• Excellent interpersonal skills and ability to interact with staff at all levels.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.