Director – Lead of Clinical Read-out Team

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Site Name: Belgium-Rixensart, Belgium-Wavre

Posted Date: Oct 7 2022

Director – Lead of Clinical Read-out Team

Are you energized by a scientific leadership role that allows you to shape scientific strategy and advance the delivery of our vaccine’s projects?

If so, this Director role could be an exceptional opportunity to explore. You will have full autonomy to lead the clinical read-out strategy for our vaccine clinical development projects from early research through to development phase.

As Director, the Senior Clinical Read-out Team Lead (CRT-L) has a pivotal leadership role to ensure project needs are translated in the appropriate clinical read-out strategy and implemented according to plans: he/she will have a dual leadership role: as the lead of the cross-departmental CRT, the senior CRT-L has full accountability for defining and implementing the clinical read-out strategy for the Projects. As the lead of the Clinical Laboratory Science (CLS) department Project-related consolidation team, the director is accountable for aligning all CLS roles related to the Project to ensure delivery to plan.

The Project-related CRT is a cross-functional team made of experts from CLS, Preclinical, Clinical, Regulatory, Biostatistics, Vaccine Development. The CRT contributes to the Project with robust scientific expertise to establish the clinical laboratory read-out strategy of the Project. Clinical laboratory assays include all laboratory tests (immunology, microbiology, diagnostic assays, safety labs) including those using innovative technologies performed to demonstrate the clinical safety, immunogenicity, and efficacy of the vaccines/Immunotherapeutic. Most Vaccine trials rely on non-routinely available immunological or microbiological markers as the primary endpoint to measure vaccine’ immunogenicity or efficacy.

The CLS Project-related consolidation team includes senior scientists from Clinical Immunology and Microbiology Sciences, Lab Study Managers from Clinical Sample Strategy & Management, Lab Managers from Clinical Read-Out Laboratories as well as the Business Analysts and delivers Project-related CLS deliverables in time, with scientific robustness and within budget. The Director, Senior CRT-L is also member of the Clinical Science Team, and of the Vaccine Development Team (VDT)/Discovery Project Team (DPT) that define the overall development strategy of new vaccines.

Key Responsibilities include, but are not limited to: 

Project Facing

• Leads the cross-functional Project-related Clinical Read-out Team (CRT) (see above).
• Single responsible for negotiation between CLS and Project to define immunological and microbiological endpoints and the associated clinical read-out strategy.
• Accountable for CLS scientific and operational input (incl budget/timelines) to the Project taking into consideration input from relevant functions from the consolidation team.
• Challenges assay demand/level of study endpoints considering project needs, scientific relevance, regulatory requirements, and cost-efficiency/capacity/smart risk taking.
• Accountable to identify, escalate and monitor project related CLS risks /mitigation plans
• Accountable for reliable communication (scientific; operational; timelines, budget) to the Clinical Science Team and the Vaccine Development Teams.
  

Interaction Outside GSK

• Leads interactions with Regulatory Authorities (RA) on topics related to Clinical Assays through regulatory organization processes; Obtain effective contribution from Clinical Immunology/Applied Microbiology Senior/Expert Scientists as appropriate.
• Whenever relevant, contributes with CLS scientific experts to scientific engagement with external experts on assays.
  

Within Clinical Laboratory Science Department

• Engages and leads CLS cross-functional consolidation team to ensure coherent and reliable scientific and operational support from CLS stakeholders; cascade project information of relevance for CLS.
• Partners with the Business Analysts to ensure adequate capture of project needs and escalation of resources risks and issues, including for concomitant serologies.
• Escalates to CLS Governance major risks.
  

Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• PhD in Immunology or Microbiology (Immunology is preferred) or closely related disciplines.
• Significant experience/methodical understanding of vaccine assay development.
• 10 years of experience from a highly regulated environment (preferably in pharmaceutical industry).
• Ability to federate a team in matrix environment around ambitious scientific projects
• Ability to motivate and consolidate demands, aligning the delivery of results to the laboratory.
• Ability to defend projects and influence stakeholders on the merits of the project and its strategy.
• Excellent verbal and written communication skills.
  

Preferred Qualifications

If you have the following characteristics, it would be a plus:

• Prior experience in vaccine development (regulatory, preclinical or clinical research, clinical laboratories)
  

Why GSK?

GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.  

 

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. 

Find out more:  Annual Report 2021 

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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