Associate Director, Diagnostic Lead

Site Name: USA - Pennsylvania - Upper Providence, USA - Massachusetts - Waltham Posted Date: Mar 29 2022 GSK Diagnostic (Dx) team members execute precision medicine approaches to drug development by collaborating with the GSK cross functional biomarker network, with clinical teams and with external Dx partners. The Dx lead implements GSK diagnostic strategies including technical, clinical, regulatory, commercial, intellectual property and business development components by leading Dx projects and work streams according to agreed deliverables, timelines, and budget. Responsibilities include The Dx associate director is responsible for the following: Help develop and lead end-to-end Dx strategy, including companion diagnostics, within early- and late-stage therapeutic clinical studies to align all Dx development milestones with drug and clinical development milestones and overall biomarker strategy. Oversee all technical aspects of development, validation, and clinical implementation of the Dx assays within a clinical study. Collaborate with clinical operations, Dx regulatory, and sample management to ensure Dx 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 Dx project. Accountable for all aspects of Dx development with external partners to develop, validate and implement Dx tests required for specific clinical studies. Supports regulatory interactions by contributing to the writing and the review of companion diagnostic portions of briefing documents, informed consents, clinical protocols, schedule of activities, clinical study reports, 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 translational and clinical study teams, drug and Dx regulatory, project management, finance, business operations Dx commercial and IVD partner joint project team members to ensure timely dissemination of information to appropriate levels. Provides frequent clinical study updates related to Dx project deliverables to management and to study level matrix teams, both internally and externally. 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? Basic Qualifications: MS degree. Three or more years experience, in a drug development setting Three or more years experience inclinical development, translational science discovery science, translational science, or clinical development within a drug development setting. Three or more years expeinence in drug development, particularly clinical trial design and execution. Three or more years experience in clinical biomarker investigation including biomarker operations and data management. Preferred Experience: PhD degree Oncology therapeutic area expertise. Experience translating a biomarker from discovery or early stage clinical to registrational studies. Performing due diligence and auditing vendors for clinical test execution. Understanding of IVD development and regulatory filing of companion diagnostic devices. Broad knowledge of technical platforms that include immunohistochemistry, immunoassay, proteomics, PCR, DNA sequencing including next generation sequencing, whole exome sequencing, whole genome sequencing RNA sequencing, and other, novel assay technologies (digital pathology, liquid biopsy, multiplex technologies). Detail oriented with strong organization skills. Exceptional written and verbal communication skills. Good track record working within a matrix team environment. 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. Dx (including companion diagnostic) product development (pre-submission packets, SRD and IDE authoring and HDE/510k/PMA documentation) for class II and/or class III devices. Understanding of IVD development including design history file evaluation, risk assessments and all related analytical and clinical validation requirements. Statistical analysis plan development, and Dx analysis required to support regulatory submissions. Knowledge of Ex-US testing and regulatory landscape. Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. *LI-GSK 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). 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