Senior Non-Clinical Manager

£58000 - £65000 per annum
  1. Permanent
London
  1. Clinical Operations, Clinical Trial Administration
Posted:12/01/2021
BBBH15726

Hobson Prior are looking for a Senior Non-Clinical Manager to join a leading pharmaceutical organisation on a permanent basis, where you will be based in London. Our client focuses on the development of cell and gene therapy research across the UK.

Job Responsibilities:

  • Providing advice to internal and external stakeholders on non-clinical packages.in support of regulatory filings, including gap analysis and the design and conduct of studies.
  • Support non-clinical managers during programme execution to ensure compliance with and adherence to project plans, regulatory requirements and to identify, evaluate and rectify problems; maintaining good communication with the project manager.
  • Prepare nonclinical aspects of regulatory documents to meet business needs and agreed time, cost and quality standards.
  • Familiar with detail of regulatory agency non-clinical safety requirements for cell and gene based therapies and GLP regulations.
  • Develop protocols and review study reports as well as other essential documents required to perform non-clinical studies.
  • Work with Business Development to ensure new opportunities are progressed and our capabilities effectively communicated.
  • Help to ensure that the non-clinical business has a strong external and internal scientific profile, this will include the job holder's own participation in industry conferences and events.
  • Participate in appropriate, non-clinical focussed, industry bodies where appropriate.
  • Ensure that strong links are maintained with business development, communications and other operational areas in order to keep an integrated approach to ATMP development solution provision.
  • This a senior position but will have no direct reports the building of relationships and having influence in a matrix environment is critical.

Key Skills:

  • High level interpersonal, communication skills and emotional intelligence.
  • Experience of standard Microsoft packages.
  • A positive attitude towards learning, personal and professional development and travel.
  • Resilient, with the ability to manage multiple and varied tasks and prioritise workload within a fast-paced professional environment, with a strong attention to detail.

Requirements:

  • Experience of working on non-clinical aspects of novel cell and gene therapies.
  • Experience of animal models for assessment of efficacy, pharmacology and safety.
  • A PhD (Biological Sciences) with a minimum of 10 years' experience (or BSc with commensurate industry experience) in research and development including non-clinical study strategy, study design and management.
  • A proven history of management skills in project delivery.
  • Willingness to travel.

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.

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