- 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 PlanCompliance of each study assigned to them as Study managementStudy risk, timeline, budget and deliverable and client communication managementCoordination of data analysis and study closeoutStudy Lead TrainingInformation 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
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Principal Scientist - London, United Kingdom - hVIVO
Description
Overview
hVIVO are seeking a Principal Scientisit ( Immunology or Virology ) to act as our SME providing consultative advice across multiple projects and throughout the business.
hVIVO conducts human challenge clinical trials. The end goal of our clinical trials is to potentially eradicate common illnesses like the common cold and flu completely – or at least make treatment of them as easy and effective as possible. Volunteers are central to the work that we do. Our studies focus on testing new treatments on real people, in a safe, controlled, clinical environment.
The Principal Scientist will take a lead role in the scientific development of all lab operational staff. Working with line managers develop training plans and material and deliver study lead / study management training program.
This is a client facing role, involving detailed scientific discussions to support clients in the setup of their projects. That include needing a detailed technical understanding of all lab assays and processes, as well as detailed understanding of the fields of virology or immunology.
In addition, this role is responsible for analysing and reporting scientific and strategic risks and options and making their recommendations to senior management.
Main Responsibilities
Skills & Experiences
1st Degree in relevant scientific subject or equivalent
PhD in relevant scientific subject
Expert Virology or Immunology knowledge as it relates to hVIVOs 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 desireable.
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