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Executive Director, Diagnostics Precision Medicine

3 months ago

Collegeville, Pennsylvania, United States GlaxoSmithKline Full time
Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, USA - Massachusetts - Waltham
Posted Date: Aug

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 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 with experience in the pharmaceutical and/or IVD industry or B.S or M.S. with pharmaceutical and/or IVD industry experience.
  • 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.


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

Why GSK?

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

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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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.

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