The Associate Principal/ Principal Clinical Outcome Assessment (COA) Endpoint Strategy serves as the subject matter expert for COA endpoint strategy, endpoint development, COA regulatory strategy, and COA instrument science in client engagement and project delivery. This role brings deep expertise in COA measurement science to differentiate client solutions through expert-driven, highly insightful endpoint strategies. The role acts as a trusted advisor to pharmaceutical and biotechnology sponsors and represents us as an external scientific thought leader while ensuring internal scientific quality and best practices. Key responsibilities include:
Client Strategy Leadership & Scientific Differentiation
Develop COA endpoint strategies across clinical development programs, including primary and key secondary endpoint positioning in consulting projects.
Bring COA expertise into client meetings, workshops, and strategic discussions.
Differentiate proposals and client solutions through expert-driven COA strategy narratives.
Translate emerging scientific and regulatory expectations into actionable client recommendations.
Regulatory-Grade Endpoint Strategy & FDA Engagement
Advise sponsors on development and justification of COA endpoint strategies for regulatory interactions.
Support preparation for and participation in FDA meetings as the COA subject matter expert.
Guide sponsors on evidence expectations, context of use, and fit-for-purpose COA strategies.
COA Instrument Development Leadership
Provide scientific leadership in the development of new COA instruments from concept to validation-ready tools.
Lead and advise on drafting and refinement of COA instrument items, response options, recall periods, and scoring approaches.
Oversee qualitative research activities supporting content validity, including concept elicitation and cognitive interviewing.
Ensure new COA instruments are patient-centered, scientifically robust, and fit-for-purpose for clinical and regulatory use.
Internal SME Oversight & Quality Assurance
Serve as subject matter expert overseeing internal project teams executing COA strategy and development work.
Review and approve key scientific deliverables to ensure quality, rigor, and alignment with best practices.
Mentor and coach COA consultants, supporting capability development across the organization.
Business Development & Practice Growth
Support business development through proposal leadership, solution design, and client presentations.
Contribute to the evolution of COA strategy methodologies, frameworks, and reusable assets.
External Scientific Leadership & Visibility
Maintain a strong external profile through publications, conference presentations, and scientific collaborations.
Represent us as a recognized expert in COA science and endpoint strategy.
דרישות:
Essential experience, skills and education required.
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 המשרה מיועדת לנשים ולגברים כאחד.