Site Name: USA - Pennsylvania - Upper Providence, GSK House, USA - Maryland - Baltimore, USA - Massachusetts - Boston, USA - North Carolina - Durham, USA - Pennsylvania - Philadelphia Posted Date: Jan 25 2022 As an Associate Direction of Patient Centered Outcomes (PCO) for Specialty Care & General Medicines (SCGM) you will apply specialized technical expertise in support of GSK's drug portfolio to support Patient Reported Outcomes (PRO)/Clinical Outcome Assessment (COA) strategies. GSK's PCO-SCGM team has an integral role in in the development of integrated evidence plans to ensure that strong COA strategies support a patient-centric understanding of our specialty drugs and general medicines, with opportunities or as needed support in oncology medicines and vaccines. Our mission is to deliver ‘do more, feel better' by implementing strong measurement science to capture the patient voice in demonstrating the value of our products to patients, physicians, payers and regulators. The team has educational backgrounds across a range of PRO/COA disciplines and experience in pharmaceutical, regulatory and academic settings. We work in close partnership across GSK functions including clinical development, regulatory affairs, value evidence and outcomes and patient focused drug development. We are well connected with external initiatives exploring innovative approaches to define, implement and interpret patient centric endpoints in drug development. We want to ensure that we have a focused view of our overall goals for the value of patient centric outcomes in drug development. We want to ensure that each development program has a well-characterized innovative PRO/COA strategy defined early in development with plans to develop evidence supporting those endpoints. We build rigor into implementation of PROs into our clinical trials. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Define and implement strategies for development and implementation of PRO/COA across GSKs drug portfolio, with opportunities or as needed support in oncology medicines and vaccines. Coordinate and lead the development, validation, analysis, interpretation and utilization of instruments aimed at measuring PRO/COA in the context of clinical trials and/or observational studies Ensure PROs are implemented appropriately in clinical trials, including writing relevant portions of the clinical trial protocols, training investigative site personnel on PRO principles and appropriate administration of PROs in the clinical trials Collaborate with clinical and statistical teams to ensure that PRO/COA are appropriate analyzed and described in statistical analysis plans, study reports and publications Support the preparation of relevant sections of documentation and communication and questions for regulatory agency meetings, support and/or participate in meetings at regulatory agencies, and provide robust evidence in support of submission activities Prepare abstracts and manuscripts presenting PRO results from clinical and PRO development and validation studies, aligned with publication strategy Develop awareness of scientific, regulatory developments across GSK's drug development programs incorporating new methodology and activities to establish communication with key outcomes research opinion leaders; Keep up to date with methodologies and guidelines (including those from Regulatory Authorities) and communicate findings to VEO and functional groups as needed. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Master's or Doctoral degree in Psychology, Psychometrics, Social Sciences, Outcomes Research, Health services research, Epidemiology, Pharmacy or a closely related discipline Minimum 3 years of experience in a related role Demonstrated experience with COA development and implementation in a pharmaceutical environment. Preferred Qualifications: If you have the following characteristics, it would be a plus: Master's degree or PhD in Psychology, Psychometrics, Social Sciences, Outcomes Research, Health services research, Epidemiology, Pharmacy or a closely related discipline Experience in pharmaceuticals, particularly in drug development, with demonstrated experience in clinical trial planning and execution Clear understanding of the FDA Patient Reported Outcomes Guidance Experience with managing PRO development and validation projects. Strong background in statistical methods for the evaluation of PROs/COA endpoints. Understanding of healthcare markets and regulatory and reimbursement decision making, especially in relation to the global use of PRO data in drug development. Understanding of the evolving methods and regulatory environment with respect PRO/COA Strong communication skills, with stakeholder engagement from operations through executive levels 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. 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