Site Name: USA - Massachusetts - Waltham, UK - Hertfordshire - Stevenage, USA - California - San Francisco, USA - Pennsylvania - Philadelphia Posted Date: Sep 4 2024 Are you interested in developing, integrating, and implementing innovative biomarker strategies for Oncology clinical development programs, including validation and integration of biomarker assays into clinical trials? If so, the Clinical Biomarker Lead role within Precision Medicine could be an ideal opportunity to explore. Responsibilities for this challenging opportunity include: Lead and/or contribute to clinical asset biomarker strategy within early and late-stage clinical development antibody drug conjugate (ADC) programs to generate data that informs on target engagement, pharmacodynamics, mechanism of action and patient selection. Represent Precision Medicine Biomarker team at Clinical Matrix Teams (CMT) and clinical trial study teams (CST). As part of the CMT and CST, establishing clear...

Site Name: USA - Massachusetts - Waltham, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Philadelphia Posted Date: Sep 3 2024 Are you interested in developing, integrating, and implementing innovative biomarker strategies for Oncology clinical development programs, including validation and integration of biomarker assays into clinical trials? If so, the Clinical Biomarker Lead role within Precision Medicine could be an ideal opportunity to explore. Responsibilities for this challenging opportunity include: Lead and/or contribute to clinical asset biomarker strategy within early and late-stage clinical development antibody drug conjugate (ADC) programs to generate data that informs on target engagement, pharmacodynamics, mechanism of action and patient selection. Represent Precision Medicine Biomarker team at Clinical Matrix Teams (CMT) and clinical trial study teams (CST). As part of the CMT and CST, establishing clear decision-making criteria to enable...

GlaxoSmithKline We're currently looking to expand our Bioanalysis and Biomarkers Platforms (BBP) department within Precision Medicine and seeking an Associate Director to join with strong exposure to PK and Biomarker Immunoassay end points. As the successful candidate, you'll join GSK in a high visibility role where you'll be at the forefront of medicine while managing the full life cycle of GSKs studies. Your skills as a bioanalytical scientist with drug development and regulatory understanding will help you working with internal and external partners to deliver bioanalytical endpoints for clinical studies across the GSK portfolio. You will serve as the subject matter expert (SME) on PK and Biomarkers data deliverables using various immunoassay platforms (e.g., ELISA, Gyros, MSD, Quanterix), and work closely with internal biomarker leads to define the necessary Context of Use for the data and ensure supporting analytical methods are fit for purpose. As a bioanalytical...

Site Name: Collegeville TSA, UK - Hertfordshire - Stevenage Posted Date: Sep 5 2024 The Associate Director of Clinical Imaging is accountable for providing multimodality imaging guidance and expertise; delivering imaging endpoints and solutions for early to late-stage trials in Neuroscience, Respiratory, Immunology, Dermatology, Hepatology, Renal and GI; and identifying and developing imaging biomarkers to enable decision-making. Primary responsibilities will be identification, selection, and delivery of imaging endpoints for clinical trials in Neuroscience, although other therapeutic areas will be in scope. Studies are executed through externalized trials with CROs, internal and external collaborations, and analysis of imaging databases. GSK’s Clinical Imaging group is part of the Clinical Biomarkers and Correlative Sciences group and sits within the Precision Medicine organization which broader strategic focus on using technologies to select the right-patient and...

GlaxoSmithKline The Associate Director of Clinical Imaging is accountable for providing multimodality imaging guidance and expertise; delivering imaging endpoints and solutions for early to late-stage trials in Neuroscience, Respiratory, Immunology, Dermatology, Hepatology, Renal and GI; and identifying and developing imaging biomarkers to enable decision-making. Primary responsibilities will be identification, selection, and delivery of imaging endpoints for clinical trials in Neuroscience, although other therapeutic areas will be in scope. Studies are executed through externalized trials with CROs, internal and external collaborations, and analysis of imaging databases. GSK's Clinical Imaging group is part of the Clinical Biomarkers and Correlative Sciences group and sits within the Precision Medicine organization which broader strategic focus on using technologies to select the right-patient and right-dose. This role will have a strong networking component to...

Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, USA - Massachusetts - Waltham, USA - North Carolina - Durham Posted Date: Aug 28 2024 We’re currently looking to expand our Bioanalysis and Biomarkers Platforms (BBP) department within Precision Medicine and seeking an Associate Director to join with strong exposure to PK and Biomarker Immunoassay end points. As the successful candidate, you’ll join GSK in a high visibility role where you’ll be at the forefront of medicine while managing the full life cycle of GSKs studies. Your skills as a bioanalytical scientist with drug development and regulatory understanding will help you working with internal and external partners to deliver bioanalytical endpoints for clinical studies across the GSK portfolio. You will serve as the subject matter expert (SME) on PK and Biomarkers data deliverables using various immunoassay platforms (e.g., ELISA, Gyros, MSD, Quanterix), and work closely with...

Site Name: USA - Massachusetts - Waltham, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence Posted Date: Aug 27 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...

Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage Posted Date: Aug 26 2024 We’re currently looking to expand our Bioanalysis and Biomarkers Platforms (BBP) department within Precision Medicine and seeking an Associate Director to join with strong exposure to LC-MS PK and biomarker end points. The role is based in the R&D hub in Upper Providence US. As the successful candidate, you’ll join GSK in a high visibility role where you’ll be at the forefront of medicine while managing the full life cycle of GSKs studies. Your skills as a bioanalytical scientist with drug development and regulatory understanding will help you working with internal and external partners to deliver bioanalytical endpoints for clinical studies across the GSK portfolio. As a senior BESM, you will manage the bioanalytical support externalized to CRO partners covering method development, assay transfer / validation (including cross validation), and work closely with...

Site Name: USA - Pennsylvania - Upper Providence Posted Date: Aug 26 2024 The Director Digital Biomarkers and Analytics is responsible for developing “fit for purpose” Digital Endpoint strategy to enable GSK ’s portfolio with Data driven decision making . Developing Machine learning models to identify the right digital measures/endpoints that correlate to severity of the disease by analyzing digital Biomarker data from sensors, wearables, and relevant historical health data. The role is also responsible for working closely with Head of Digital Biomarkers in implementing the digital biomarker roadmap for priority disease areas. The role addresses the following strategic and technical objectives : Strategic : Strategic partnership with internal stakeholders, external experts and organizations to advance the acceptance of Digital Biomarkers . Work with Senior Leaders from multiple departments (Digital Health, Regulatory Affairs, Biostat , Clinical...

Site Name: Collegeville TSA, Belgium-Wavre, Canada - Ontario - Mississauga, USA - Massachusetts - Cambridge, USA - Massachusetts - Waltham Posted Date: Aug 20 2024 Would you like to be part of GSK’s Global Epidemiology, Vaccines team, with an opportunity to drive Epidemiology strategy and studies across the spectrum of vaccine development? If so, this is an excellent opportunity to explore. Job Purpose The Associate Director in Epidemiology will support epidemiological strategy for programs led by the Epidemiology Cluster Head- Bacterial vaccines. The goal is to ensure high quality and on-time delivery of epidemiology data that will allow and support world-wide registration in compliance with the epidemiology plan, applicable good practices, and non-interventional studies standard operating procedures (SOP). As an Associate Director in Epidemiology, you will provide scientific leadership in the application of epidemiological expertise and methods to address key...