Head of Clinical Outcome Assessment and Patient-Centered Outcomes

5 days ago


London, Greater London, United Kingdom OPEN Health Full time
Job Summary

We are seeking a highly experienced and skilled Director, Psychometrics and Patient-Centered Outcomes Strategist to join our team at OPEN Health. As a key member of our Psychometrics and Patient-Centered Outcomes team, you will be responsible for overseeing and advising on the development and execution of clinical outcome assessment (COA) studies.

Key Responsibilities
  • Study Development and Execution: Oversee the design and execution of COA studies that align with international scientific standards and regulatory authorities' recommendations.
  • Team Leadership: Manage and mentor mid-level and junior team members, providing guidance and support to ensure the successful delivery of projects.
  • Business Development: Collaborate with business development, marketing, and other service areas to build greater awareness of our PCO team capabilities and identify new business opportunities.
  • Regulatory Interactions: Lead or advise on the COA-focused strategy for client interactions/submissions with regulatory agencies (FDA, EMA) and generate evidence for submission to federal regulators.
  • Research and Analysis: Oversee and advise on the development of statistical and validation analysis plans and conduct psychometric and/or quantitative analyses to meet study objectives.
  • Communication and Presentation: Present research findings to clients and other external stakeholders, including presentations at scientific congresses.
Requirements
  • Education: MSc or PhD in Biostatistics or Psychometrics, or a relevant science, such as Health economics, Public Health, Epidemiology, Pharmacoeconomics, or Psychology.
  • Experience: Strong experience in patient-centered outcomes research, including COA instrument development/psychometric validation, quantitative analysis of COA-based clinical study endpoints, and regulatory dossier development and submissions.
  • Skills: Proven track record of interacting with regulatory agencies (FDA, EMA, PMDA), fluency/proficiency in at least one of the following programming languages: R or SAS, and extensive working knowledge of relevant regulatory guidance on COAs.
  • Personal Qualities: Strong communicator (both written and verbal) with attention to detail and accuracy, strong organizational and project management skills, and a genuine interest in delivering high-quality deliverables.
About OPEN Health

OPEN Health unites deep scientific knowledge with wide-ranging specialist expertise to unlock possibilities that improve health outcomes and patient wellbeing. We work in partnership with our clients to deliver fresh thinking and solutions that make a difference.



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