Lead COA Strategy & Instrument Innovation (Senior)

IQVIA Inc

Paris

Hybrid

EUR 90,000 - 150,000

Full time

9 days ago

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Job summary

IQVIA is the leading Human Data Science Company that partners with health care institutions to measure patient experiences and improve outcomes. The Patient Centered Solutions team drives scientifically rigorous COA research, integrating patient voices into drug development and regulatory submissions.

The Associate Principal/ Principal COA Endpoint Strategy role leads strategy, development, and regulatory interactions for COA programs across therapeutic areas, mentoring teams and shaping client

Qualifications

  • Deep expertise across COA types (PRO, ObsRO, ClinRO, PerfO) and their application in clinical research.
  • Extensive experience developing COA endpoint strategies across multiple therapeutic areas.
  • Hands-on experience developing new COA instruments, including item writing and qualitative validation.
  • Experience supporting FDA-facing endpoint strategy and regulatory interactions.
  • Ability to mentor junior team members.
  • Excellent scientific writing, presentation, and stakeholder engagement skills.
  • Advanced degree (PhD, MD, PharmD, DrPH, MSc) in a relevant scientific discipline strongly preferred.
  • Strong publication record and recognized credibility in outcomes research or COA measurement science.
  • Well-developed written and verbal communication skills including presentations, chairing meetings, external conference presentations, workshop facilitation, business and report writing.
  • An entrepreneurial nature and interest in developing new client offerings and solutions and in building the capability to deliver the same.

Responsibilities

  • Develop COA endpoint strategies across clinical development programs and key secondary endpoints.
  • Bring COA expertise into client meetings, workshops, and strategic discussions.
  • Differentiate proposals through expert-driven COA strategy narratives.
  • Translate emerging scientific and regulatory expectations into client recommendations.
  • Advise sponsors on regulatory interactions and FDA meetings as COA SME.
  • Lead development of COA instruments from concept to validation-ready tools.
  • Oversee qualitative research supporting content validity, including concept elicitation and cognitive interviewing.
  • Mentor internal project teams and ensure scientific quality across work.
  • Support business development through proposal leadership and solution design.
  • Maintain external profile through publications, conferences, and collaborations.

Skills

COA types expertise
COA strategy development
COA instrument development
FDA engagements
Mentoring
Scientific writing
Publications
Communication skills
Entrepreneurial mindset

Education

Advanced degree in sciences

Job description

IQVIA is the leading Human Data Science Company that partners with health care institutions to measure patient experiences and improve outcomes. The Patient Centered Solutions team drives scientifically rigorous COA research, integrating patient voices into drug development and regulatory submissions.

The Associate Principal/ Principal COA Endpoint Strategy role leads strategy, development, and regulatory interactions for COA programs across therapeutic areas, mentoring teams and shaping client

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