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Executive Director, Diagnostics ​Precision Medicine

London

Job Type

Job Function

Medical and Clinical

Location

London

On-Site or Remote

Job Type

Salary

Competitive salary and benefits

About the Role

*Job description* *Site Name:* USA - Massachusetts - Boston, UK - London, USA - Pennsylvania - Philadelphia *Posted Date:* Jan 26 2024 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. This role will have the responsibility to deliver on the vision of equipping GSK to be a leader in precision medicine through innovation and excellence in Dx development driving value by treating the right patient with the right medicine. This leadership role will develop Dx strategies with team implementation GSK Development wide encompassing technical, development, regulatory, commercial, IP and business development efforts by leading Dx projects and work streams according to agreed deliverables, timelines and budget. In this role, you will have the opportunity to lead the development and commercialization of diagnostics and as required companion diagnostics across therapeutic areas including Oncology, Respiratory/Immunology, and infectious diseases. The Executive Director will lead by embedding a culture of collaboration, diversity, equity, and inclusion that embraces precision medicine in drug development. *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) team 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 - Be accountable for embedding a culture of collaboration, diversity, equity, and inclusion that embraces precision medicine in drug development - Manage a team to deliver on all aspects of Dx development and implementation. - Be accountable for the team members’ growth and development. - 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/reviewing 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 Development, 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 Development Liaises with: Project teams, key stakeholders, and Platform team leaders - Work and collaborate 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/reviewing of companion diagnostic portions of informed consents, clinical protocols, schedule of activities, and clinical study reports. - US Dx submission experience including, IDE, 510 (k) or PMA. - Experience with technical platforms that include IHC, immunoassay, PCR, NGS and novel assay technologies (digital pathology, liquid biopsy, multiplex technologies) - Experience in IVD development including design history file evaluation, risk assessments and all related analytical and clinical validation requirements - Experience performing due diligence and auditing vendors for Dx test placement - Experience with GCP/GCLP, CLIA, CAP, ISO15189 laboratory requirements - Experience with QSR regulations, GMP manufacturing, ISO13485, and FDA and EU medical device regulations - Experience with clinical trial design and execution (efficacy endpoints, biomarker testing), sample operations, data management and human biological specimen management) - Experience with MS Office products (Word, Excel, PowerPoint, SharePoint, Project) and remote meeting tools such as MS Teams *Preferred Qualifications:* *If you have the following characteristics, it would **be a plus:* - Experience in Diagnostic development in multiple therapeutic areas such as Oncology, Vaccines, Respiratory/Immunology, and infectious diseases. - Experience in Diagnostic test submissions and approvals in multiple therapeutic areas such as Oncology, Vaccines, Respiratory/Immunology, and infectious diseases. - Dx development and submission experience ex-US such as EU, UK, Japan, China, & S. Korea. - 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 #LI-GSK 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. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. *Important notice to Employment businesses/ Agencies* GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.

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