Site Name: USA - Massachusetts - Waltham, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence Posted Date: Sep 18 2024 Are you a professional in the diagnostics field looking to advance your career? If so, this Associate Director- Diagnostics Precision Medicine role may be an ideal opportunity to explore! As a Diagnostics (Dx) team member you will contribute to efforts to implement GSK diagnostics strategy including technical, clinical, regulatory, commercial, intellectual property and business development components by leading diagnostic projects and work streams according to agreed deliverables, timelines and budget. The aforementioned functional areas will partner with you to develop and commercialize Dx across therapeutic areas, Oncology, Vaccines, and Respiratory/Immunology. Dx team members execute precision medicine approaches in drug development through building collaboration within the GSK cross functional, translational biomarker network and with external, diagnostic partners. Responsibilities include: This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Help develop and lead end-to-end diagnostic strategy within early and late-stage therapeutic clinical studies to align all diagnostic development milestones with clinical development milestones and overall translational biomarker strategy. Accountable for all aspects of diagnostic development with external partners to develop, validate and implement diagnostic tests required for specific clinical studies. Oversee all technical aspects of development, validation and clinical implementation of the diagnostic assays within a clinical study. Collaborate with clinical operations and sample management to ensure diagnostic testing and data generation is compliant with all regulatory requirements. Exhibit timely management and delivery of projects/work streams within agreed budget. Works within, and may lead, matrix teams to ensure efficient implementation of all key deliverables for the diagnostic project. Supports regulatory interactions by contributing to the writing and the review of diagnostic portions of briefing documents, informed consents, clinical study protocols, clinical study reports, SRD, IDE and PMA regulatory submissions. Where applicable, contributes to the implementation of strategies to manage risks on clinical study timelines, budgets and goals. Contributes to decisions which balance risk/benefit with clear understanding of impact on project. Builds and maintains networks with clinical study teams, regulatory, clinical and biomarker leads, TA heads, project management, finance, business operations and IVD partner joint project team members to ensure timely dissemination of information to appropriate levels to improve transparency. Provides frequent clinical study updates related to diagnostic project deliverables to management and to study level matrix teams, both internally and externally. Liaises with asset teams, regulatory, clinical and biomarker leads, TA heads, and IVD partner joint project team members. Works with clinical, regulatory, operations, policy, BD and business unit colleagues and key leadership within project teams. Works with asset leads to ensure efficient implementation of all key deliverables for the Dx Where applicable, accountable for implementing key organizational process improvement initiatives in daily activities. Participate in the evaluation of advanced technologies for IVD and clinical biomarker development. Why You? Required Qualifications We are looking for professionals with these required skills to achieve our goals: Advanced degree in Biological sciences; Ph.D. with 3 or more years of pharmaceutical and/or IVD manufacturer experience or B.S or M.S. with 5 years or more years of pharmaceutical and/or IVD manufacturer experience Experience in clinical trial design and execution (efficacy endpoints, biomarker testing), sample operations, data management and human biological specimen management. Experience in clinical/translational biomarker investigation including biomarker operations and data management. Experience with IVD development including design history file evaluation, risk assessments and all related analytical and clinical validation requirements. Experience in technical platforms that include IHC, immunoassay, PCR, NGS and novel assay technologies (digital pathology, liquid biopsy, multiplex technologies). Experience with MS Office products (Word, Excel, PowerPoint, SharePoint, Project) and remote meeting tools such as WebEx and Microsoft Teams Preferred Experience If you have the following characteristics, it would be a plus: Therapeutic area expertise in multiple specialty areas. Performing due diligence and auditing vendors for clinical test execution. Familiarity with clinical laboratory and medical device requirements including: GCP/GCLP, CLIA, CAP, ISO15189, QSR regulations, GMP manufacturing, ISO13485, including FDA/US and EMA/EU. Diagnostic product development (pre-submission packets, SRD and IDE authoring and HDE/510k/PMA documentation) for class II and/or class III devices including: companion/ complimentary diagnostics and surrogate efficacy biomarkers. Knowledge of US and Ex-US testing regulatory landscape, including evolving IVDR requirements in the EU and HGR regulations in China. Able to manage multiple projects including assessment of workload and resourcing requirements to deliver the team’s objectives. Detail oriented with strong organization skills. Exceptional written and verbal communication skills. Good track record working within a matrix team environment. #LI-GSK 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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