Director, Clinical Lab Science, Clinical Read-out - Siena, Italia - GSK

GSK

Azienda verificata

Siena, Italia

2 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

Site Name:
Belgium-Rixensart, Cambridge MA, Italy - Siena

Posted Date:
Jun

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 laboratory 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: leading a cross-departmental team (clinical development, preclinical, clinical assay experts, regulatory), the senior CRT-L has full accountability for defining and implementing the clinical read-out strategy for dedicated Projects.

The senior CRT-L is also accountable for aligning all stakeholders within the newly created Clinical laboratories & Assays Portofolio to ensure delivery to plan.

The Senior CRT-L 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.

Key Responsibilities include, but are not limited to:

Project Facing:

Leads the crossfunctional Projectrelated Clinical Readout Team.
Single responsible for negotiation between The Clinical laboratories & Assays Portofolio and Project to define immunological and microbiological endpoints and the associated clinical readout strategy.
Accountable for scientific and operational input (incl budget/timelines) to the Project taking into consideration input from relevant functions.
Challenges assay demand/level of study endpoints considering project needs, scientific relevance, regulatory requirements, and costefficiency/capacity/smart risk taking.
Accountable to identify, escalate and monitor assayrelated risks and to establish mitigation plans.
Accountable to foster laboratory teams to focus and deliver according to plans.

Interaction outside GSK:

Leads interactions with Regulatory Authorities on topics related to Clinical Assays through regulatory organization processes; obtain effective contribution from Clinical Immunology/Applied Microbiology Senior/Expert Scientists as appropriate.

_ 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 or extensive professional experience in Immunology.
Substantial 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 ha