Director of Patient Centered Outcomes

Brentford Temporary Hybrid working
  • Opportunity to make a difference World-Leading organisation
  • Lead on the PRO / COA Strategy

About Our Client

A World-Leading Pharmaceutical and Biotechnology company providing innovation in vaccines and specialty medicines. With their Research & Development covering a variety of Therapeutic areas, our client is committed to getting ahead of disease and positively impacting health.

Job Description

These responsibilities include some of the following:

* Define and oversee the execution of strategies for the rigorous development and implementation of PRO/COAs across the specialty and primary care portfolio (with opportunities in oncology medicine and vaccines)

* Guide the development, validation, analysis, interpretation, and utilisation 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 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 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 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.

The Successful Applicant

The successful candidate will have:

  • Experience with planning and managing PRO development and validation projects
  • Clear understanding of the FDA Patient Reported Outcomes Guidance
  • Experience in pharmaceuticals, particularly in drug and vaccine development, with demonstrated experience in clinical trial planning and execution
  • Experience with planning and managing PRO development and validation projects for drug development in in a consulting and/or pharmaceutical company environment
  • 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
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally


  • Strong background in statistical methods for the evaluation of PROs/COA endpoints.
  • Understanding of health care 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 patient-reported outcomes (PRO) and clinical outcome assessments (COA)
  • Strong verbal and written communication skills, with stakeholder engagement from operations through executive levels

What's on Offer

  • Immediate Start
  • Competitive Rate
  • Work from Home
Jamie-Lee Debenham
Quote job ref
Phone number
+44 172 773 0114

Job summary

Job function
Life Sciences
Healthcare / Pharmaceutical
Contract type
Consultant name
Jamie-Lee Debenham
Consultant phone
+44 172 773 0114
Job reference
Job Nature
Hybrid working