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Head of Patient Science, Instrument Development & Thought Leadership
Job Description & How to Apply Below
Reading, Berkshire, United Kingdom time type:
Full time posted on:
Posted Todayjob requisition :
R1551833
** Join us on our exciting journey!
** IQVIATM is The Human Data Science CompanyTM, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, Technology, analytics and human ingenuity to drive healthcare forward.
** The Instrument Development and Thought Leadership Segment
** Instrument Development:
This team is responsible for the development of new clinical outcome instruments, expansion and enhancement of existing instruments, with a focus on specific priority therapeutic area. Collaborative &Y. Advisory:
Given the team’s expertise in instrument development and client consulting and delivery, team members support where appropriate client consulting engagement with the PACT team and collaborate with therapeutics centers of excellence. Thought leadership is the final area of focus:
This includes white papers, manuscripts/publications, podium presentations; posters and books. Coordination with the PACT team, clients, industry thought leaders, regulators, patient advocacy groups and other stakeholders is a critical component of our thought leadership.
** The role
** The Head of Patient and Instrument Science and Thought Leadership leads the strategic, scientific and regulatory development of Clinical Outcomes Assessments (COAs) and Composite Measures. COA’s include:
Patient-Centered Research patient-reported outcomes (PROs), observer-reported outcomes (ObsROs), and clinician-reported outcomes (ClinROs). These instruments are used by Bio Pharmaceutical and Medical Device organization in clinical trials and real-world studies and by Health Care Physicians in day-today clinical practice.
This individual is responsible for ensuring that the patient perspective is rigorously measured and incorporated into drug development, measurement endpoint strategy, regulatory submissions, and commercialization using behavioral and measurement science.
** Responsibilities:
*** Strategic Leadership:
Define instrument development strategies across therapeutic areas, ensuring alignment with Instrument Licensing & Services, R&DS Therapeutic Area Priorities and R&DS goals, FDA/EMA guidance on patient-focused drug development (PFDD), and HTA requirements.
* Scientific Excellence:
Lead the development, validation, and implementation of new and existing COA instruments, including psychometric evaluation, qualitative research, and endpoint definition. Support the Scientific & Strategic Research Consulting team in their client facing COA endpoint strategy projects as needed.
* Regulatory Engagement:
Lead interactions with regulatory bodies (FDA, EMA) regarding newly developed COAs designed to replace older declining in relevance COAs.
* Methodological Expertise:
Direct the use of advanced methodologies, with a heavy focus on Domains of Health, including Digital Measurement Plans, eCOA (electronic COA) strategies, and Patient Experience Data (PED) analytics.
* Cross-functional Collaboration:
Partner with Instrument Licensing & Services (IQVIA Quality Metric), Strategic & Scientific Research, R&DS Design & Delivery Innovation including the TSSU/Therapeutic Area COE, clinical operations, biometrics, regulatory, and commercial teams build, expand and enhance COA utility in measuring meaningful change in health.
* Team Leadership:
Mentor and build a team of experienced and burgeoning scientists, guiding them in COA methodologies and scientific best…
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