Associate Director, Specialty Care & General Medicines, Patient Centered Outcomes

Site Name: UK - London - Brentford Posted Date: Jan 31 2023 360511 Associate Director, Specialty Care & General Medicines, Patient Centered Outcomes As an Associate Director 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. In this role you will 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. Closing Date for Applications: February 26th, 2024 (COB) 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, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process. *LI-GSK Why you? Qualifications & Skills: 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 Demonstrated experience with COA development and implementation in a pharmaceutical environment. 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 Preferred Qualifications & Skills: If you have the following characteristics, it would be a plus: Clear understanding of the FDA Patient Reported Outcomes Guidance Strong communication skills, with stakeholder engagement from operations through executive levels Why GSK? Uniting science, technology and talent to get ahead of disease together GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more: Annual Report 2021 We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated. In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention. Find out more: Our approach to R&D GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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