Clinical Biomarker Group Lead Virology,
Site Name: USA - Pennsylvania - Upper Providence Posted Date: Jul 19 2021 Are you looking for a leadership role that allows you to shape and define an innovative clinical virology/biomarker strategy across GSK's growing infectious disease pipeline? Are you passionate about accelerating the delivery of transformational medicines in the Infection and Immunity disease space? Does targeting therapies to the patients who benefit most, appeal to you? As the Clinical Virology Leader within the Biomarker Group, you will have the opportunity to lead a new and growing team of clinical biomarker experts that is being created to meet the needs of GSK's growing infectious disease pipeline, including programs targeting COVID-19 and HBV. You would have responsibility for development and effective implementation of clinical virology/biomarker strategies in support of GSK's clinical stage infectious disease pipeline. Working as part of the early development / medicine development matrix teams (EDT/MDT), you will establish clear decision-making criteria to enable informed clinical decisions and integrate the biomarker strategy into the clinical development plans. The Clinical Biomarker Lead will employ cutting edge technologies and procedures to discover and implement in the clinic, virology and biomarker assays. The implementation of the virology/biomarker strategy as part of a well thought through clinical plan will ensure optimally informed decision making in drug development. This role will provide YOU the opportunity to drive key activities and responsibilities as follows: Lead a team of clinical biomarker experts who support drug discovery and development programmes across the GSK pipeline with a focus on infectious disease. Setting aligned, stretched objectives, driving performance, ensuring quality delivery, creating an environment to maximize the outcomes for the team and GSK R&D. Manage resource allocation across projects and work with Clinical Biomarker Head to ensure optimal resource allocation across the portfolio Review team clinical virology/biomarker strategies and provide direction and guidance Enable team deliverables by ensuring the availability of state-of-the art platform technologies and resource is optimal to support biomarker portfolio Work with Head of Clinical Biomarkers to ensure that biomarker strategy aligns with overall Clinical Pharmacology Experimental Medicine strategy Perform Biomarker Virology Lead role for key projects - which will include the following: Developing and maintaining project clinical virology/biomarker strategy including approaches to monitor resistance development and identify pharmacodynamic and predictive biomarkers Representing virology/biomarker strategy at the EDT/MDT, study teams and Protocol Review Forum Responsibility for virology/biomarker-related elements of study trial design, protocol development, implementation and conduct, including addressing regulatory and health authority questions. Working with Contract Research Organisations, internal technology groups, and collaborators to deliver quality clinically validated virology/biomarker data, on time and on budget. Responsibility for the generation of clinical virology/biomarker study reports. Responsibility for the clinical virology/biomarker regulatory submission data packages, from Phase 1 through to post marketing activities. Working with Research Unit project biologist to ensure alignment of preclinical and clinical biomarker strategies Developing companion diagnostic strategies for validation, implementation and regulatory approval of predictive biomarkers Ensuring alignment of biomarker outputs with data management, statistics, and modelling/simulation requirements As required, supporting the expansion of mechanism and disease understanding to generate insights that can be leveraged in indication expansion and marketing Internal: This is a Career Ladder role and we have flexibility to appoint at G5 or G4, based on level and type of Experience. External: For this position, we have flexibility on the level of appointment across Director grades, based on the level and type of experience Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Deep expertise in applying networking skills and stakeholder management Track record and knowledge of multiple virology/biomarker platforms and their application in therapeutic areas Competence and/or a recognized expert in critiquing the scientific validity of research/development Infection and Immunity focused Biomarker strategies approaches. Applies scientific skills to influence experimental design and data interpretation that impacts across drug discovery/development. Contributor to scientific rationale for the development of long term biomarker and translational strategy PhD-educated scientist (or equivalent) with at demonstrated experience in the application of biomarkers in clinical trials (5 years+) Recognised team leader with proven people-management skills Extensive experience in conducting clinical trials and working as part of a clinical study team Knowledge and track-record of working to GCP principles Expertise in the discovery, validation and clinical implementation of biomarkers Strong understanding and experience of predictive biomarkers, including diagnostic development Preferred Qualifications: In addition to the minimum qualifications, the ideal candidate will possess the following: Strong interpersonal skills and ability to thrive in a matrix environment Ability to influence teams and key stakeholders with a proven track record of success Why GSK? At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best. When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it's about you being motivated to do your best work, in a place where you can be you, feel good and keep growing. Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers. 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