Hobson Prior are looking for a Non-Clinical Manager to join a growing biotech in London on a permanent basis. In this role you will take responsibility for non-clinical safety. As the Non-Clinical Manager, you will assess the non-clinical feasibility of candidate cell and gene therapy programmes, plan studies to meet the regulatory requirements, complete non-clinical gap analyses and represent the organisation and Collaborating Organisations in Regulatory Agency Scientific and Innovation meetings.

Job Responsibilities:

• You will provide advice to collaborators/clients on their non-clinical packages in support of regulatory filings, including gap analysis and the design and conduct of studies in agreement with Head of Non-Clinical Safety.
• Monitor non-clinical programme progress to ensure compliance with and adherence to project plans, regulatory requirements and to identify, evaluate and rectify problems.
• Familiar with detail of regulatory agency non-clinical safety requirements for cell and gene-based therapies and GLP regulations.
• Prepare non clinical aspects of regulatory documents (briefing documents, CTAs, INDs, amendments, safety reports, annual reports, etc.) to meet business needs and agreed time, cost and quality standards in agreement with the Head of Regulatory Affairs.
• Develop protocols and review study reports as well as other essential documents required to run non-clinical studies.
• Apply the principles of the 3R's to all non-clinical programmes.
• Develop and maintain constructive working relationships with Competent Authority and Health Authority contacts, contributing to strategies to influence regulators as required towards appropriate risk evaluation and management
• Provision of non-clinical work-packages for grant applications.

Key Skills:

• Excellent interpersonal, verbal and written communication skills.
• Flexibility towards work assignments, new learning and travel.
• Ability to manage multiple and varied tasks and prioritise workload with a strong focus on attention to detail and excellent organisational skills.
• Ability to work quickly and accurately, with limited supervision.
• Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives.

Requirements:

• PhD (Biological Sciences) with a minimum of 5 years' experience in research and development including non-clinical study design and monitoring, or equivalent industry experience.
• Experience of novel cell and gene therapies preferable, or novel therapeutic product development experience.
• Experience of Pharma/University collaborative programmes.
• Experience of preparing/delivering PowerPoint presentations and generating study reports is a prerequisite.
• Experience of animal models used to assess safety and efficacy of novel therapeutics.
• Documented training in GLP.
• Experience of regulatory documentation preparation and interactions with regulatory agencies.
• Experience in grant application preparation.
• Experience in generation of peer reviewed publications.

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.