Job Reference: J5632003
Updated On: 07/08/2019
Status: Now Interviewing
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Role OverviewWe are currently looking for a Non-Clinical Manager to join an exciting Cell and Gene Therapy company based in London. As the Non-Clinical Manager you will be responsible for assessing the feasibility of candidate cell and gene therapy programmes, plan studies to meet the regulatory requirements, complete nonclinical gap analyses, represent the company and company partners in Regulatory Agency Scientific and Innovation meetings.
Key Duties and ResponsibilitiesYour duties as the Non-Clinical Manager will be varied however the key duties and responsibilities are as follows:
1. Providing advice to collaborators / clients on their nonclinical packages in support of regulatory filings, including gap analysis and the design and conduct of studies in agreement with Head of Non-Clinical Safety.
2. Monitor nonclinical programme progress 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.
3. Develop protocols and review study reports as well as other essential documents required to run nonclinical studies.
4. Provision of nonclinical work-packages for grant applications.
Role RequirementsTo be successful in your application to this exciting opportunity as the Non-Clinical Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in a Scientific discipline along with experience leading Non-Clinical / Pre-Clinical Studies.
2. Proven industry experience working within a GLP environment and ideally interacting with regulatory agencies.
3. A working knowledge and practical experience with cell and gene therapies would be highly desirable.
Key Words: Non-Clinical | Pre-Clinical | NonClinical | PreClinical | Cell Therapy | Gene Therapy | Stem Cells | GLP | Assay Development | ATMP |
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