Associate Director/Director, Patient Reported Outcomes

Location: 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 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 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 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. 

Ready to shape the future of healthcare?

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 (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/COA-related results from clinical trials and/or PRO/COA development and validation studies.
• Maintain awareness of scientific and regulatory changes across GSK’s development programs.
• Pursue ongoing learning to understand and adopt evolving methodologies and guidelines (including those from regulatory authorities) and communicate findings to cross functional groups as needed.

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, with demonstrated experience in clinical trial planning and execution.
• Clear understanding of the FDA COA Guidance.
• Experience with managing COA development and validation projects.
• Strong background in statistical methods for the evaluation of COA endpoints.
• Understanding of healthcare markets and regulatory and reimbursement decision making, especially in relation to the global use of COA data in drug and vaccine development.
• Understanding of the evolving methods and regulatory environment with respect to COAs.
• 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, as the role involves interface with a wide range of stakeholders internally and externally.

CLOSING DATE for applications: 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, 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.

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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

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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