Non Clinical Manager
|Job Title:||Non Clinical Manager|
|Salary:||£45000 - £55000 per annum, Benefits: bonus, generous pension, life insurance, health insurance plus others.|
|Contact Name:||James Hume|
|Job Published:||February 07, 2020 11:51|
The company are a centre of excellence that is at the forefront of creating a viable and sustainable cell and gene therapy industry. Their headquarters are in central London where they have built a leading multidisciplinary team that has the ability to take a therapy from concept through the development cycle to the market. With sector leading expertise to overcome the challenges face commercialising these therapies providing the scientific, clinical and commercial expertise needed to overcome the challenges. Once therapies have crossed the translational gap they have the capabilities to successfully complete non clinical studies to then take therapies through clinical trials with therapies now entering phase III trials.
The role of Non - Clinical Manager is an influential position where you will be responsible for leading the activities for the feasibility assessment of cell and gene therapy programmes. Taking the lead for the development the non-clinical strategies to ensure therapies progress through these stages to achieve successful regulatory submissions.
You will be working directly with collaborators on their nonclinical programmes to support regulatory filings covering the gap analysis and the design studies that you will oversee throughout their life cycle. Monitoring programmes so that they adhere to project plans, regulatory requirements, to identify, evaluate, and rectify issues that may arise. As the Project Manager you will prepare aspects of regulatory documents that includes briefing documents, CTA’s, IND’s, amendments, safety reports etc.
This is an influential role where you will have the opportunity to use your expertise to provide advice on proceedings such as wider strategies and approaches as well as the completion of other regulatory documents. Giving you the broad experience to move to a more senior or technical role going forwards as the company continues to grow.
Desired Skills and Experience:
For the Non Clinical Project Manager opportunity you will need to have a higher qualification (e.g. MSC or PhD) in a relevant area combined with experience in the design of non clinical studies for ATMP’s, Cell Therapies, Gene Therapies, Biologics, Biopharmaceuticals, or Novel Therapeutic product development experience. You will need to be experienced in GLP regulations with experience in the use of animal models for the assessment of safety and efficacy of therapies. With experience in the preparation of regulatory documentation for submission. With experience in dealing regulatory bodies, collaborators, external partners, grant applications, and collaborative programmes is advantageous.
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