Executive Director-Diagnostics RIIRU

Executive Director-Diagnostics RIIRU

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together. Find out more:
Our approach to R&D

Are you energized by a highly visible scientific leadership role that allows you to drive and shape scientific innovation? If so, the Executive Director, Diagnostics (Dx) role could be an exciting opportunity to explore.

As a Diagnostics Leader, you will lead efforts to enhance innovation through the use of world-class and cut-edge data, tools, and techniques to drive scientific excellence. This role will have responsibility to deliver on the vision of equipping GSK to be a leader in precision medicine through excellence in scientific discovery, clinical translation and Diagnostic development driving value by treating the right patient with the right medicine.

This leadership role will develop and implement GSK Research and Development Diagnostic strategy encompassing technical, development, regulatory, commercial, IP, AIML, and business development efforts by leading Diagnostic projects and work streams according to agreed deliverables, timelines and budget. This role will lead the development and commercialization of diagnostics and as needed companion diagnostics focusing on the therapeutic areas Respiratory, Immunology, Inflammation, and Infectious Diseases.

The Executive Director will embed a culture of patient centric innovation and inclusivity that embraces diagnostic approaches in drug development through building collaborations between groups that work in the biomarker diagnostic continuum within GSK and externally.

Responsibilities:

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Act as a Diagnostics (Dx) leader to deliver on the vision of equipping GSK to be a leader in Respiratory, Immunology, Inflammation, and Infectious Diseases through Dx development driving value by identifying the right patient for the right medicine
• Lead, manage, and develop a Dx team of 3+ members.
• Participate in leadership meetings to create cross-functional diagnostic strategies.
• Develop Dx strategies that can benefit multiple GSK assets across Respiratory, Immunology, Inflammation, and Infectious Diseases therapeutic areas.
• Define the Dx strategy from an asset perspective to support global drug registration
• Lead the diagnostics strategy within therapeutic programs to align all diagnostic development milestones with clinical development milestones and overall biomarker strategy
• Be accountable for all aspects of Dx development with an external IVD partner to develop, validate, register Dx tests for prospective patient selection
• Oversee all technical aspects of development, assay validation and clinical implementation of the selected assays, Authoring of companion diagnostic portions of informed consents, clinical protocols, schedule of activities, clinical study reports, IDE, PMA, IVDR and all other regulatory submissions
• Collaborate with clinical operations and sample management to ensure diagnostic testing and data generation is compliant with all regulatory requirements
• Ensure team exhibits timely management and delivery of projects/work streams within agreed budget
• Must be able to manage multiple projects and workstreams across TAs and R&D, including assessment of workload and resourcing requirements to deliver the team's objectives
• Maintain an up-to-date knowledge of all assigned projects, strategy and progress. Clearly and concisely report projects progress and outcomes
• Ensure learnings and best practices are shared across R&D and the Respiratory, Immunology, Inflammation, and Infectious Diseases Research Unit.
• Work with regulatory, policy, BD, TAs and business unit colleagues and key leadership within project teams
• Work with project leads to ensure efficient implementation of all key deliverables

Why you?

Basic Qualifications:

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

• Bachelor's or Master's degree with extensive experience in the pharmaceutical or IVD industry
• Experience in the successful submission of IVD including companion diagnostics
• People management experience leading global cross-functional matrix teams
• Experience defining Dx strategy from an asset perspective to support global drug registrations
• Experience leading the diagnostics strategy within therapeutic programs to align all diagnostic development milestones with clinical development milestones and overall biomarker strategy
• Experience developing the Dx strategy with an external IVD partner to develop, validate, register Dx tests for prospective patient selection
• Experience in overseeing all technical aspects of development, assay validation and clinical implementation of the selected assays; Authoring of companion diagnostic portions of informed consents, clinical protocols, schedule of activities, clinical study reports, IDE, PMA, IVDR and all other regulatory submissions

Preferred Qualifications:

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

• PhD in Biological Sciences and extensive experience in the pharmaceutical or IVD industry strongly preferred
• Experience in diagnostics development in the therapeutic areas Respiratory, Immunology, Inflammation, and/or Infectious Diseases.
• Ability to discriminate between critical and non-critical activities and to follow established processes while identifying areas for process improvement
• Attention to detail with excellent planning, time management and organizational skills
• Excellent communication and presentation skills, high- level negotiation skills and the ability to resolve conflict in a constructive manner
• Experience in innovative platforms and technologies to support Dx testing at home or in a physician's office.
• Experience in the development of AIML Dxs.

Join us in shaping the future of diagnostics and making a difference in healthcare. Apply today!

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

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