ABOUT THIS ROLE
Northreach has partnered with a fast growing biotech company based in London.
The company is rapidly moving in clinical trial and as part of the company growth, we are recruiting for a professional with experience as a Nonclinical Study Manager.
- Vendor selection, protocol preparation, study initiation, management and scientific oversight of IND-enabling, GLP non-clinical safety studies placed at CROs.
- Vendor selection, oversight of development and qualification of assays required for sample analysis within IND enabling safety studies, such as ELISpot assays, anti-drug antibody (ADA) titre assays, neutralising assays, biodistribution assessment (by qRT-PCR, in situ hybridisation, immunohistochemistry).
- Write, edit, and review study reports for regulatory submissions and for internal records.
- Ensure all required documentation and experimental write-ups are completed and approved in a timely manner.
- Coordinate team to ensure meeting study timelines and to action follow-up activities to ensure adherence to agreed Milestones by external partners.
- Work closely with the members of Preclinical Research to evaluate therapeutic candidates in normal and diseased ocular models.
- Collect and log experimental data from studies performed externally. Conduct statistical analysis of data sets. Ensure validity and quality of data generated externally.
- Prepare materials, including graphs and spreadsheets. to portray results for presentations, patent filings and manuscripts for publication.
- Present findings to colleagues in lab meetings and at external meetings as required.
- Work cross-functionally with other departments.
- Assist in the supervision of technical staff.
- Comply with company training and policies.
THE IDEAL CANDIDATE
- PhD or equivalent number of years of experience in Biochemistry, Molecular Virology, Immunology, Ophthalmology or related discipline.
- Experience in non-clinical in vivo GLP safety/toxicology studies.
- Understanding of and experience with GLP toxicity requirements across different territories (e.g. EU, USA). Ensure that nonclinical deliverables are in accordance with regulations, standards, and guidelines.
- Experience in experimental design with multiple species such as rodent, canine, feline, porcine, primate and lagomorpha.
- Proficiency in molecular and cell biology techniques such as ELISA, western blot analysis, immunohistochemistry and in situ hybridisation.
- Ability to apply scientific and technical expertise in molecular biology, biochemistry and tissue engineering to impact the future of new drug candidate development for clinical use.
- Ability to work to priorities and deliver projects on time.
- High level organisational skills.
- High level analytical capability and attention to detail.
- Ability to communicate complex information clearly.
- Ability to apply and troubleshoot relevant models, techniques and methods, and to develop new ones when necessary.
- Ability to assess resource requirements and deploy them effectively.
- Ability to encourage research culture in others.