Hobson Prior are looking for a Head of Non-Clinical Safety to join a growing biotech in Central London on a permanent basis. In this role you will take responsibility for non-clinical safety.

Job Responsibilities:

• You will lead the determination and implementation of optimal non-clinical strategies for each programme in alignment with the strategy and key stakeholders.
• Accountable for assessment of the non-clinical safety packages and requirements for all the programs including gap analyses and risk-based assessments.
• Responsible for design, planning and oversight of non-clinical safety studies, including GLP regulatory toxicology and selection and oversight of contract providers.
• Familiar with detail of regulatory agency (EMA and FDA) non-clinical safety requirements for cell-based therapies and GLP regulations and able to produce and review regulatory documentation for scientific advice meetings and competent authority submissions.
• Lead compilation and submission of the selection and development of appropriate assays and biomarkers for use in non-clinical and clinical studies, including supervision of laboratory work and participation in lab work as required
• Maintain up to date expert knowledge of regulations for ATMPs in the UK and EU with a high level of awareness of relevant regulations in other jurisdictions e.g. US and Japan.
• Ensure that the Client applies best practice and the principles of the 3R's to all non-clinical programmes
• Lead and develop the non-clinical team, including appropriate training.

Key Skills:

• Excellent interpersonal, verbal and written communication skills.
• Ability to take initiative and work independently; sense of urgency in completing assigned tasks.
• Flexibility towards work assignments, new learning and travel.
• Ability to manage multiple and varied tasks and to prioritise workload with excellent attention to detail.

Requirements:

• A minimum of 10 years' or more experience in research and development including leadership of GLP activities and immune based therapies.
• Previous experience of developing advanced therapy medicinal products (ATMP) and leading ATMP non-clinical safety programs is desirable.
• Experience of working with novel therapies where there are unknowns and novel approaches and flexibility is desirable.
• Documented training in GLP, GCLP and GCP.
• Experience of regulatory dossier Non-clinical Overviews (Module 4 of CTD/IND/IMPD), IB etc preparation.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back 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.