Are you looking for a health outcomes role that allows you to leverage your PRO/COA strategy expertise? If so, this could be an exciting opportunity for you to explore.
*This role could be Director or Associate Director level depending on candidate experience.
As a Director of Patient-Centered Outcomesfor Specialty Care and General Medicines (PCO-SPC), 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 specialty care and general medicine portfolio .
GSK's PCO-SPC team plays an integral role in 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-SPC team may support efforts in oncology medicine and vaccines as well. 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.
The PCO-SPC team maintains a sharp focus on the value of patient-centric outcomes across the entire specialty care and general medicines 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.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- Define and oversee the execution of strategies for the rigorous development and implementation of PRO/COAs across GSK's specialty and primary care portfolio (with opportunities in oncology medicine and vaccines).
- 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) to ensure the value of patient-centric endpoints is communicated clearly and that PRO/COAs are implemented and analyzed appropriately in clinical trials (and are accurately described in statistical analysis plans, study reports and publications).
- 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 to support GSK's patient-centric endpoint strategies.
- Support broader publication strategy by planning for and contributing to external publications (e.g., scientific abstracts and peer-reviewed manuscripts) which present PRO-related results from clinical trials and/or PRO development and validation studies.
- Maintain awareness of scientific and regulatory changes across GSKs specialty and primary care drug development programs.
- Pursue ongoing learning to understand and adopt evolving methodologies and guidelines (including those from regulatory authorities) and communicate findings to VEO and functional groups as needed.
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, Public Health, Epidemiology, Pharmacy, or a closely related discipline
- Minimum 7 to 10 years of experience in a related role, including demonstrated experience with PRO/COA development and implementation in a consulting and/or pharmaceutical company environment.
If you have the following characteristics, it would be a plus:
- Experience in pharmaceuticals, particularly in drug and vaccine development, with demonstrated experience in clinical trial planning and execution
- Clear understanding of the FDA Patient Reported Outcomes Guidance
- Experience w ith planning and 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 and vaccine development.
- Understanding of the evolving methods and regulatory environment with respect PRO/COA
- Strong verbal and written communication skills, with stakeholder engagement from operations through executive levels
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 organization 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.
~We Look Forward To Working With You !~
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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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