Vaccine Development Leader, Seasonal Influenza Vaccine

Job description

Nombre del sítio: Cambridge Park Drive, Belgium-Wavre, GSK House, Italy - Siena, Rockville Vaccines
Fecha de publicación: Feb 28 2024

VICE PRESIDENT – VACCINES DEVELOPMENT LEAD, SEASONAL INFLUENZA

POSITION SUMMARY

The Vaccine Development Lead (VDL) will strategically lead the global development of the seasonal influenza vaccine. The VDL will act as the single point of accountability for the vaccine from Phase I through to approval in the first major market, as well as manage post-launch life-cycle programs. The goal is to deliver differentiated vaccines of value. By working with the various stakeholders across R&D and Commercial, the VDL will define the strategic vision and operational plan for the vaccine, aligning it with the overall organizational strategy.

This is a truly exciting opportunity for an outstanding candidate to lead and drive all aspects of the development of an asset, bringing in and directing expertise from a number of different functions, ensuring its successful outcome and commercial launch. The role will be key in driving the refinement of a promising early pipeline, and by extension the successful growth and development of GSK as a business.

The VDL will create and lead the matrix Vaccine Development Team (VDT), which has responsibility for representing all the various Vaccine R&D and commercial disciplines required to optimally deliver the development of the vaccine (including clinical development, medical affairs, safety, regulatory, commercial and product development, and manufacturing).

GSK’s SEASONAL INFLUENZA DEVELOPMENT PROGRAM

Currently, available flu vaccines are suboptimal and mRNA vaccines have the potential to revolutionize the flu market, which is estimated to exceed £8 billion by 2028. mRNA vaccines can be manufactured quickly and easily, and they can be readily adapted to keep pace with changes in the virus, making them an ideal technology for responding to emerging and evolving flu strains.

In collaboration with CureVac, GSK has announced preliminary positive Phase I data for a multivalent mRNA flu vaccine. Influenza vaccine development is one of the highest priorities for GSK. The asset is currently in Phase II.

ACCOUNTABILITY AND KEY RESPONSIBILITIES

·  Acts as a single point of accountability in GSK for all aspects of the influenza vaccine in development globally from commit to Phase I to approval in first major markets.
·  Delivers differentiated vaccines of value for patients, stakeholders, and markets, through an evidence package that supports regulatory approval, market access, and product life cycle.
·  Establishes a compelling vision for the vaccine; positions the vaccine within the Vaccine R&D strategy taking the competitive landscape into account.
·  Translates GSK’s strategy into asset strategy and actionable plans for multiple R&D functions.
·  Energizes and motivates the Vaccine Development Team (VDT) to drive performance, supports differentiated development for team members, oversees the performance of VDT, and partners with line managers to enhance overall performance.
·  Provides key support to the Vaccine Commercialization Team (VCT) post-approval in first major markets ensuring that the VDT provide optimal support to both registration and life cycle management.
·  Prioritizes and maximizes the asset’s portfolio options, including developing multiple indications. Makes clear evidence-based go / no go / accelerate decisions, based on whether the results fulfil the strategy set out for the vaccine, and identify clear inflection points.
·  Embeds core processes, including cost efficiency, adoption of new technology, risk identification and management, and compliance with policy.
·  Identifies and aligns resources (people and financial), team objectives and strategies behind the vision to ensure successful project completion.
·  Proactively identifies unmet medical needs that could be addressed through line extensions.
·  Enhances patient focus by incorporating the voice of the patient into development plans.
·  Promotes organizational reputation and drives asset value by engaging and negotiating with internal and external stakeholders.
·  Ensures quality and compliance oversight in line with R&D expectations and project needs; assures quality of data and science.
·  Prioritizes and manages asset portfolio options to meet budget constraints.
·  Ensures excellence in execution of all governance processes, including oversight of all studies, pharmacovigilance, scientific engagement, and promotional practices.

CANDIDATE PROFILE – QUALIFICATIONS AND EXPERTISE

Basic Qualifications

·  PhD, PharmD, or MD.
·  Vaccine drug development experience, including having led development programs and filing experience (BLA / NDA / MAA submissions) as a core responsibility.
·  Experience in product development and/or commercial, especially in late phase development (from PoC onwards), clinical trial management, post-approval studies, regulatory and manufacturing compliance.
·  Experience working with regulators and regulatory requirements, including exposure to legal and government frameworks within and across global geographies.
·  Experience creating the strategy for pre- and post-marketing studies and driving the lifecycle process.
·  Experience working across functions, including research, commercial, regulatory, global medicine supply, legal, regions, etc.
·  Experience in the healthcare environment and exposure to all key external stakeholders.

Preferred Qualifications

·  Highly developed ethics and integrity, with demonstrated ethical medical decision-making skills.
·  Understands the entirety of R&D across the development/commercial life cycle to allow impact across all functions, including discovery, late-stage development, regulatory, manufacturing, and commercial.
·  Track record of success working in highly complex, matrixed, global, and multi-disciplinary organizations with high accountability, minimal authority, and multiple lines of reporting.
·  Strong people management, leadership, and motivational skills.
·  Ability to build relationships and create authentic alignment while leading high performing teams in a collaborative and purposeful manner to achieve defined objectives.
·  Having previously operated in a similar role or environment to the GSK Medicine/Vaccine Development Leader, with end-to-end asset leadership including overseeing clinical development, medical affairs, safety, regulatory, commercial, product development and manufacturing, will be a distinct advantage.

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why Us?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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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