GlaxoSmithKline LLC
Associate Director/Director, Patient Reported Outcomes
GlaxoSmithKline LLC, Collegeville, Pennsylvania, United States, 19426
GlaxoSmithKline LLC Associate Director/Director, Patient Reported Outcomes
Reference #: 403116Site Name: UK - London - New Oxford Street, Canada - Ontario - Mississauga, USA - Pennsylvania - Upper ProvidencePosted Date: Aug 28 2024Location: GSK HQ London UK, USA- Pennsylvania and Mississauga-Canada. Flexibility will be given to those within these locations.As an Associate Director/Director of Patient-Centered Outcomes, you will apply technical expertise to plan and support evidence development strategies for Patient Reported Outcomes (PRO)/Clinical Outcome Assessment (COA)-related endpoints across GSK's portfolio.GSK's PCO team plays an integral role in the development of integrated evidence plans to ensure that strong PRO/COA strategies support a patient-centric understanding of our drug development. As opportunities and needs arise, the PCO team may support efforts in respiratory and immunology, oncology medicine, and vaccines. Our mission is to implement strong measurement science to capture the patient voice in demonstrating the value of our products to patients, physicians, payers, and regulators.The PCO team maintains a sharp focus on the value of patient-centric outcomes across the entire GSK portfolio. We want to ensure that each clinical program has a well-characterized, innovative PRO/COA strategy that is defined early in the development lifecycle and has clear plans to develop evidence that supports PRO/COA-related endpoints.Key Responsibilities include, but are not limited to:Define and oversee the execution of strategies for the rigorous development and implementation of PRO/COAs across GSK's portfolio.Guide the development, validation, analysis, interpretation, and utilization of PRO/COA instruments in the context of clinical trials and/or observational studies.Work cross-functionally (e.g., clinical operations, biostats teams, regulatory) to ensure the value of patient-centric endpoints is communicated clearly and that PRO/COAs are implemented and analysed appropriately in clinical trials.Support key communications with regulatory bodies by developing targeted questions related to the PRO/COA endpoint strategy and identifying the critical evidence needed for meetings.Support broader publication strategy by planning for and contributing to external publications (e.g., scientific abstracts and peer-reviewed manuscripts).Maintain awareness of scientific and regulatory changes across GSK's development programs.Pursue ongoing learning to understand and adopt evolving methodologies and guidelines.Why you?Basic Qualifications:Bachelor's degree in psychology, Psychometrics, Social Sciences, Outcomes Research, Health services research, Epidemiology, Pharmacy, or a closely related discipline.Considerable experience in a related role with COA development and implementation in a pharmaceutical environment.Experience from the pharmaceutical Industry, particularly in drug and vaccine development.Clear understanding of the FDA COA Guidance.Strong background in statistical methods for the evaluation of COA endpoints.Understanding of healthcare markets and regulatory and reimbursement decision making.Strong communication skills, with stakeholder engagement from operations through executive levels.Preferred Skills & Qualifications:Master's degree in a relevant subject with excellent problem-solving, analytical, and critical thinking skills.Ability to thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.Outstanding listening and collaborative team working and leadership skills.CLOSING DATE:
11th September 2024 (EOD)Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role.Why GSK?GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together.As an Equal Opportunity Employer, we are open to all talent. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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Reference #: 403116Site Name: UK - London - New Oxford Street, Canada - Ontario - Mississauga, USA - Pennsylvania - Upper ProvidencePosted Date: Aug 28 2024Location: GSK HQ London UK, USA- Pennsylvania and Mississauga-Canada. Flexibility will be given to those within these locations.As an Associate Director/Director of Patient-Centered Outcomes, you will apply technical expertise to plan and support evidence development strategies for Patient Reported Outcomes (PRO)/Clinical Outcome Assessment (COA)-related endpoints across GSK's portfolio.GSK's PCO team plays an integral role in the development of integrated evidence plans to ensure that strong PRO/COA strategies support a patient-centric understanding of our drug development. As opportunities and needs arise, the PCO team may support efforts in respiratory and immunology, oncology medicine, and vaccines. Our mission is to implement strong measurement science to capture the patient voice in demonstrating the value of our products to patients, physicians, payers, and regulators.The PCO team maintains a sharp focus on the value of patient-centric outcomes across the entire GSK portfolio. We want to ensure that each clinical program has a well-characterized, innovative PRO/COA strategy that is defined early in the development lifecycle and has clear plans to develop evidence that supports PRO/COA-related endpoints.Key Responsibilities include, but are not limited to:Define and oversee the execution of strategies for the rigorous development and implementation of PRO/COAs across GSK's portfolio.Guide the development, validation, analysis, interpretation, and utilization of PRO/COA instruments in the context of clinical trials and/or observational studies.Work cross-functionally (e.g., clinical operations, biostats teams, regulatory) to ensure the value of patient-centric endpoints is communicated clearly and that PRO/COAs are implemented and analysed appropriately in clinical trials.Support key communications with regulatory bodies by developing targeted questions related to the PRO/COA endpoint strategy and identifying the critical evidence needed for meetings.Support broader publication strategy by planning for and contributing to external publications (e.g., scientific abstracts and peer-reviewed manuscripts).Maintain awareness of scientific and regulatory changes across GSK's development programs.Pursue ongoing learning to understand and adopt evolving methodologies and guidelines.Why you?Basic Qualifications:Bachelor's degree in psychology, Psychometrics, Social Sciences, Outcomes Research, Health services research, Epidemiology, Pharmacy, or a closely related discipline.Considerable experience in a related role with COA development and implementation in a pharmaceutical environment.Experience from the pharmaceutical Industry, particularly in drug and vaccine development.Clear understanding of the FDA COA Guidance.Strong background in statistical methods for the evaluation of COA endpoints.Understanding of healthcare markets and regulatory and reimbursement decision making.Strong communication skills, with stakeholder engagement from operations through executive levels.Preferred Skills & Qualifications:Master's degree in a relevant subject with excellent problem-solving, analytical, and critical thinking skills.Ability to thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient.Outstanding listening and collaborative team working and leadership skills.CLOSING DATE:
11th September 2024 (EOD)Please take a copy of the Job Description, as this will not be available post closure of the advert. When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role.Why GSK?GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together.As an Equal Opportunity Employer, we are open to all talent. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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