Associate Principal / Principal, Clinical Outcome Assessment (COA) Strategy Consulting

IQVIA AG seeks a senior expert to lead Clinical Outcome Assessment (COA) strategy, instrument development, and regulatory consulting for pharmaceutical clients in Switzerland.

This position functions as the primary scientific authority for COA endpoint strategy, regulatory guidance, and instrument science within client engagements. The expert serves as a trusted advisor to biotechnology and pharmaceutical sponsors, representing the firm as an external thought leader in the field.

Responsibilities

• Design COA endpoint strategies for clinical programs, including the positioning of primary and key secondary endpoints.
• Guide sponsors on the development and justification of COA strategies for regulatory submissions.
• Act as the subject matter expert during FDA meetings and other regulatory interactions.
• Provide scientific leadership in creating new COA instruments from initial concept to validation.
• Lead the drafting and refinement of instrument items, response options, recall periods, and scoring methods.
• Oversee qualitative research activities, such as concept elicitation and cognitive interviewing, to ensure content validity.
• Manage internal project teams executing COA strategy and development work.
• Review and approve scientific deliverables to ensure quality and adherence to best practices.
• Mentor and coach consultants to build organizational capability.
• Support business development through proposal leadership, solution design, and client presentations.
• Maintain an external profile via publications, conference presentations, and scientific collaborations.

Requirements

• Deep expertise in 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 in 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.

Nice to have

• Advanced degree (PhD, MD, PharmD, DrPH, MSc) in a relevant scientific discipline.
• Strong publication record and recognized credibility in outcomes research or COA measurement science.

What the company offers

• Opportunity to become part of a recognized global leader in patient-focused research.
• Organization that encourages and invests in continuous professional and personal development.
• Apply business and leadership skills in an entrepreneurial and multi-disciplinary team.

About the company

IQVIA positions itself as The Human Data Science Company, leveraging data and science to help healthcare clients find better solutions for their patients. The PCS team leads the industry in the science of measuring the patient experience, pairing strategic consulting expertise with technical scientific knowledge to design and execute scientifically rigorous research.

• Focus on using data and science to help healthcare clients find better solutions for their patients.
• Leadership in the science of measuring the patient experience.
• Combination of strategic consulting expertise with technical scientific knowledge.