Join us on our exciting journey!
IQVIA™ is The Human Data Science Company™, 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 BioPharmaceutical 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 practices. Participate in acquisition science and staff integration as relates to COA assets and scientific SME’s.
- External Representation: Act as a recognized expert in the field, representing the company at scientific conferences (e.g., ISPOR, ISOQOL, CPATH, etc) and in industry consortia.
Required Qualifications & Skills – our ideal candidate will have:
- Education: Advanced degree (PhD, Master’s, or equivalent) in Psychology, Behavioral measurement, Health Services Research, Epidemiology, Pharmacy, Public Health, or a related discipline.
- Experience: 10+ years of professional experience in COA/outcomes research within pharmaceutical, CRO, or consultancy settings, with a strong track record of publications.
- Technical Knowledge: Deep understanding of COA methodology, psychometrics, FDA/EMA regulatory guidelines on patient-focused drug development, and qualitative research methods.
- Communication: Excellent scientific writing and verbal skills, with the ability to communicate complex data to regulatory bodies and internal senior leadership.
- Influencing & Relationship Development: Proven influencing skills at the senior management level, have the presence and credibility to engage and influence senior leaders across multi-geographies and functions. Demonstrated success building effective relationships with a broad spectrum of global stakeholders (e.g., senior leaders, business and technical teams, GTM, and customers)
- Leadership: Proven experience in managing high-performing teams, building talent, and influencing cross-functional stakeholders. Promotes information sharing and demonstrates flexibility to work in a fast paced, dynamic environment and effectively manage change.
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and
Whatever your career goals, we are here to ensure you get there!
We invite you to join IQVIA™.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
