Principal Virologist - Laboratory Project Management

Overview

hVIVO are seeking a Principal Scientist (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, they will develop training plans and materials and deliver study lead/study management training programs.

This is a client-facing role, involving detailed scientific discussions to support clients in the setup of their projects. This includes needing a detailed technical understanding of all lab assays and processes, as well as a detailed understanding of the fields of virology or immunology.

In addition, this role is responsible for analyzing and reporting scientific and strategic risks and options and making recommendations to senior management.

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 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 utilizing 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 resources 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

Skills & Experiences

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 organizational 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.