GlaxoSmithKline
Executive Director, Diagnostics Precision Medicine
GlaxoSmithKline, Collegeville, Pennsylvania, United States, 19426
Site Name:
USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, USA - Massachusetts - WalthamPosted Date:
Jul 30 2024Are you energized by a highly-visible scientific leadership role that allows you to drive and shape scientific innovation? If so, the
Executive Director, Diagnostics Precision Medicine
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 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 include
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 precision medicine 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 Precision Medicine strategies.Develop enterprise-wide Dx strategies that can benefit multiple GSK assets across therapeutic and vaccine 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 Liaises with: Project teams, EDLs, DPU heads, TA heads, and Platform team leaders.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:PhD in the Biological Sciences and 10 years of pharmaceutical or IVD industry experience with a minimum of 7 years in the pharmaceutical industry, or B.S or M.S. with 15 years of pharmaceutical or IVD industry experience with a minimum of 7 years in the pharmaceutical industry.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: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.
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USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, USA - Massachusetts - WalthamPosted Date:
Jul 30 2024Are you energized by a highly-visible scientific leadership role that allows you to drive and shape scientific innovation? If so, the
Executive Director, Diagnostics Precision Medicine
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 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 include
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 precision medicine 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 Precision Medicine strategies.Develop enterprise-wide Dx strategies that can benefit multiple GSK assets across therapeutic and vaccine 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 Liaises with: Project teams, EDLs, DPU heads, TA heads, and Platform team leaders.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:PhD in the Biological Sciences and 10 years of pharmaceutical or IVD industry experience with a minimum of 7 years in the pharmaceutical industry, or B.S or M.S. with 15 years of pharmaceutical or IVD industry experience with a minimum of 7 years in the pharmaceutical industry.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: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.
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