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Lead Scientist
2 months ago
We are seeking a highly experienced and skilled Senior Scientist to join our team at hVIVO. As a Principal Scientist, you will play a key role in the scientific development of our lab operations and will be responsible for providing consultative advice across multiple projects and throughout the business.
Main Responsibilities- Provide full Study Management function to include responsibilities of the following for each study assigned:
- Input into the clinical protocol and compilation of the Analytical Plan
- Compliance of each study assigned to them as Study management
- Study risk, timeline, budget and deliverable and client communication management
- Coordination of data analysis and study closeout
- Study Lead Training
- Information for virus dossier (preclinical)
- Have an expert knowledge in the field of virology with excellent working knowledge of all hVIVO current assays as well as a thorough understanding of developments in assay technologies in the wider scientific community
- Expert understanding of the mechanism of action of viral infection and antiviral drugs and vaccines as well as the clinical manifestations of disease
- Expert knowledge of the Viral Challenge Model and clinical study design such that they can advise on the scientific aspects of design both to clients as well as key internal stakeholders involved in the study design process
- Provide technical advice and expertise in clinical study design, in line with client requirements at the early study stage utilising a thorough understanding of the GCP and regulatory framework governing the conduct of studies
- Managing the study-support processes and delivery from the study-support team
- Oversee the initiation of the study/analytical plans and assign resource for the execution of scientific experiments
- Make recommendations for assay and clinical model development and influence Company scientific strategy in these areas by liaison with hLab leadership team
- Attend initial client meetings and conferences with Business Development as a hVIVO technical expert in virology, viral challenge model and GMP Virus
- Take responsibility along with Laboratory Operations senior management in developing the proposal and costing potential internal/external studies
- An understanding of the contracts, finance and scope change process
- Proactively able to identify where the project is required to be conducted outside the scope of the contract and escalate such incidences to senior management
- Promote effective teamwork among project team members and other departments within hLab leadership team and clinical groups so as to meet agreed timelines and budget
- 1st Degree in relevant scientific subject or equivalent
- PhD in relevant scientific subject
- Expert Virology or Immunology knowledge as it relates to hVIVO's Viral Challenge Model
- Excellent communication and motivational skills
- Strong planning and organisational skills
- Good working knowledge of GCP labs and ICHGCP standards
- Ability to supervise and mentor others and work as part of a team
- Prior experience of project management
- Prior experience of providing technical support to senior key stakeholders and clients
- Prior experience of line management, a Masters Degree in relevant scientific subject and working knowledge of current H&S regulations would also be desirable