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 Dx development driving value by treating the right patient with the right medicine.
This leadership role will develop and implement GSK R&D wide Dx strategy encompassing technical, development, regulatory, commercial, IP, AIML, and business development efforts by leading Dx 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 across all therapeutic areas including, Respiratory/Immunology, Infectious Diseases, Vaccines, and Oncology.
The Executive Director will embed a culture of patient centric innovation and inclusivity that embraces precision medicine approaches in drug development through building collaborations between groups that work in the biomarker diagnostic continuum within GSK and externally.
Responsibilities:
1. Act as a Diagnostics (Dx) leader to deliver on the vision of equipping GSK to be a leader in precision medicine through Dx development driving value by identifying the right patient for the right medicine
2. Lead, manage, and develop a Dx team comprised of senior talent
3. Participate in leadership meetings to create cross-functional Precision Medicine strategies.
4. Develop enterprise-wide Dx strategies that can benefit multiple GSK assets across therapeutic and vaccine areas.
5. Define the Dx strategy from an asset perspective to support global drug registration
6. Lead the diagnostics strategy within therapeutic programs to align all diagnostic development milestones with clinical development milestones and overall biomarker strategy
7. Be accountable for all aspects of Dx development with an external IVD partner to develop, validate, register Dx tests for prospective patient selection
8. 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
9. Collaborate with clinical operations and sample management to ensure diagnostic testing and data generation is compliant with all regulatory requirements
10. Ensure team exhibits timely management and delivery of projects/work streams within agreed budget
11. 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
12. Maintain an up-to-date knowledge of all assigned projects, strategy and progress. Clearly and concisely report projects progress and outcomes
13. Ensure learnings and best practices are shared across R&D Liaises with: Project teams, EDLs, DPU heads, TA heads, and Platform team leaders
14. Work with regulatory, policy, BD, TAs and business unit colleagues and key leadership within project teams
15. Work with project leads to ensure efficient implementation of all key deliverables
Basic Qualifications:
16. PhD in the Biological Sciences with experience in the pharmaceutical and/or IVD industry or B.S or M.S. with pharmaceutical and/or IVD industry experience.
17. People management experience leading a team directly and global cross- functional matrix teams
18. Experience defining Dx strategy from an asset perspective to support global drug registrations
19. Experience leading the diagnostics strategy within therapeutic programs to align all diagnostic development milestones with clinical development milestones and overall biomarker strategy
20. Experience developing the Dx strategy with an external IVD partner to develop, validate, register Dx tests for prospective patient selection
21. 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:
22. Ability to discriminate between critical and non-critical activities and to follow established processes while identifying areas for process improvement
23. Attention to detail with excellent planning, time management and organizational skills
24. Excellent communication and presentation skills, high- level negotiation skills and the ability to resolve conflict in a constructive manner
25. Experience in innovative platforms and technologies to support Dx testing at home or in a physician’s office.
26. Experience in the development of AIML Dxs.
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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.
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