Save JobEmail job Back to Search Job Description Summary Similar JobsOpportunity to make a difference World-Leading organisationLead on the PRO / COA StrategyAbout Our ClientA 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 DescriptionThese 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 ApplicantThe successful candidate will have:Experience with planning and managing PRO development and validation projectsClear understanding of the FDA Patient Reported Outcomes GuidanceExperience in pharmaceuticals, particularly in drug and vaccine development, with demonstrated experience in clinical trial planning and executionExperience with planning and managing PRO development and validation projects for drug development in in a consulting and/or pharmaceutical company environmentMaster's or Doctoral degree in Psychology, Psychometrics, Social Sciences, Outcomes Research, Health services research, Public Health, Epidemiology, Pharmacy, or a closely related disciplineMinimum 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 environmentCommitted to delivering high quality results, overcoming challenges, focusing on what matters, execution.Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externallyDesirable: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 levelsWhat's on OfferImmediate StartCompetitive RateWork from HomeContactJamie-Lee DebenhamQuote job refJN-082023-6160496Phone number+44 172 773 0114Job summaryJob functionLife SciencesSubsectorClinicalSectorHealthcare / PharmaceuticalLocationBrentfordContract typeTemporaryConsultant nameJamie-Lee DebenhamConsultant phone+44 172 773 0114Job referenceJN-082023-6160496Job NatureHybrid working
