Associate Principal / Principal, Clinical Outcome Assessment (COA) Strategy Consulting
hace 4 días
Madrid
Experteer Overview As a COA Strategy lead, you will shape endpoint strategies and instrument science across clinical programs. You act as a scientific advisor to sponsors, translating regulatory expectations into actionable plans. You’ll lead development of COA instruments, ensure patient-centered, robust measures, and support FDA interactions. You will mentor teams, contribute to thought leadership, and help differentiate IQVIA solutions with expert COA storytelling. This role blends science, strategy, and external visibility to advance patient-focused outcomes. Compensaciones / Beneficios • Develop COA endpoint strategies across clinical development programs and key endpoint positioning in consulting projects • Bring COA expertise to client meetings, workshops, and strategy discussions • Differentiate proposals with expert-driven COA strategy narratives • Translate emerging scientific and regulatory expectations into client recommendations • Advise sponsors on regulatory interactions and COA endpoints for FDA engagements • Lead development of new COA instruments from concept to validation-ready tools • Oversee instrument item writing, response options, recall periods, and scoring approaches • Oversee qualitative research supporting content validity (concept elicitation, cognitive interviewing) • Ensure COA instruments are patient-centered, scientifically robust, and fit-for-purpose • Act as internal SME, review key deliverables, and mentor COA consultants • Support business development through proposals, solution design, and client presentations • Maintain external visibility via publications, conferences, and collaborations Responsabilidades • Deep expertise across COA types (PRO, ObsRO, ClinRO, PerfO) and their clinical application • Experience developing COA endpoints across multiple therapeutic areas • Hands-on COA instrument development including item writing and validation • Experience supporting FDA-facing endpoint strategy and regulatory interactions • Ability to mentor junior team members • Excellent scientific writing, presentation, and stakeholder engagement • Strong publication record and credibility in outcomes research or COA measurement science • Strong written and verbal communication, workshop facilitation, and external presentations • Entrepreneurial mindset and interest in developing client offerings and capability Requisitos principales • hybrid work model • continuous professional development • entrepreneurial, multi-disciplinary team environment • opportunities for external visibility and publications