Director, Patient Centered Outcomes

3 weeks ago

Collegeville, United States GSK Full time

**Site Name**: USA - Pennsylvania - Upper Providence, UK - London - Brentford

**Posted Date**: Apr 25 2024
**GSK site preferred locations**: Upper Providence, PA. UK - GSK House. On-site presence of 2-3 days per week average is anticipated. Additional flexible arrangements considered on case by case basis.

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 including specialty and primary care, oncology and vaccines. Our mission is to deliver _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, Biostatistics, Medical Affairs 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 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 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) 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 functional groups as needed.

**_ Why you?_**

**Basic Qualifications**:

- 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+ years of experience in a related role, including demonstrated experience with PRO/COA development and implementation in a consulting and/or pharmaceutical company environment.
- Experience in pharmaceuticals, particularly in drug and vaccine development, with demonstrated experience in clinical trial planning and execution
- Experience with FDA Patient Focused Development Guidances
- Experience with planning and managing PRO development and validation projects.
- Experience in inclusion of COA endpoints in clinical trials and analysis of PRO data

**Preferred Qualifications**:

- If you have the following characteristics, it would be a plus:_
- Ability to proactively manage internal stakeholders through to executive levels
- Strong verbal and written communication skills
- Understanding of psychometric methods for the validation 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

LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

**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 bill

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