Required Associate Principal / Principal, Clinical Outcome Assessment (COA) Strategy Consulting
The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients. We offer a broad range of solutions that harness advances in healthcare information, technology, analytics, and human ingenuity to drive healthcare forward.
The Patient Centered Solutions team (PCS)
The PCS team leads the industry in the science of measuring the patient experience. We pair strategic consulting expertise with technical scientific knowledge to design and execute scientifically rigorous research that incorporates the patient voice into the development and commercialization of new medicines. This research includes qualitative (e.g., patient interviews, focus groups), quantitative (e.g., clinical outcome assessments (COAs)/patient-reported outcomes (PROs), preference research) and passive (e.g., digital health technology tools) approaches to understand patient, caregiver and physician experiences and expectations of disease and treatment.
Why join?
Become part of a recognized global leader in patient-focused research
Keep growing with an organization that encourages and invests in continuous professional and personal development
Apply your business and leadership skills in an entrepreneurial and multi-disciplinary team
Continue challenging yourself by addressing the toughest client issues, working across multiple geographies and solutions in a dynamic and crucial field for the industry
Make a difference to patients by enabling the successful approval or launch of new treatments with features that are truly patient-centric
Responsibilities:
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.
Requirements: 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.
This position is open to all candidates.