As a Director of Patient-Centered Outcomes(PCO) for Oncology 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 oncology portfolio .
GSK's PCO-Oncology 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 oncology medicines. As opportunities and needs arise, the PCO-Oncology team may support efforts in Specialty Drugs and General Medicines (SDGM) 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, consulting 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-Oncology team maintains a sharp focus on the value of patient-centric outcomes across the entire oncology 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:
Why you? Basic Qualifications:
- Define and oversee the execution of strategies for the rigorous development and implementation of PRO/COAs across GSK's oncology portfolio (with opportunities in SDGM 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
*LI-GSK Why GSK?
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges 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 geneticsscience; 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 diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas 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 culturethat isambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership ofgoals and support to succeed; andwhere we do the right thing
. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together.
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