Description
Title: Senior Director, Mixed Methods
Department: Prospective Studies
Status: Full-time, Exempt
Location: U.S. or U.K.
Company Overview
Clinical Outcomes Solutions (COS) is a global research consulting group providing 360° support and services across all facets of clinical outcomes research to assist with value-driven decisions for informing patient care. Our mission is to advance the science of patient outcomes through innovative solutions and deep partnerships with our clients. We are dedicated to transforming clinical outcome assessment (COA) research into a powerful tool for improving patient lives and creating value for our clients. With a passionate commitment to excellence, we strive to drive measurable impact on patient outcomes and make a meaningful difference in patients' lives worldwide.
Role Summary
The Senior Director leads the Prospective Studies Business Unit and serves as a senior mixed-methods Clinical Outcome Assessment (COA) scientist. This role provides strategic leadership for the design and execution of qualitative and quantitative measurement research, including outcome measure development, modification, psychometric validation, and regulatory-grade evidence generation. The Senior Director collaborates cross-functionally with Qualitative and Quantitative Science teams to develop innovative research strategies that support clinical development programs and deliver scientifically rigorous, patient-centered outcomes research.
Responsibilities
Design Endpoints:
Lead or co-lead end-to-end development of de novo and fit-for-purpose COA instruments (PROs, ObsROs, ClinROs, and PerfOs) from concept to validation-ready tools.
Mixed-Methods Integration: Oversee qualitative research (concept elicitation, cognitive interviewing) and quantitative psychometric validation (reliability, validity, responsiveness, scoring).
Regulatory Alignment: Interact with the cross functional COS scientific and Evidence Synthesis teams on COA-specific regulatory interactions (FDA, EMA) regarding endpoint positioning, Context of Use (CoU), and labeling claims.
Evidence Generation:
Collaborate with internal and external cross-functional teams (Clinical Development, Regulatory, Market Access, and Outcomes Research) to embed patient voice data into clinical trials and non-interventional studies.
Support the Prospective Studies and Research Operations teams at COS on non-interventional data collection efforts.
Serve as the internal Subject Matter Expert (SME) on measurement science, training clinical operations and study teams on data quality standards for Mixed Methods studies.
Drive external visibility through peer-reviewed publications, congress presentations, and participation in industry working groups.
Requirements
Requirements
Master’s or Ph.D. in Health Sciences, Psychometrics, Psychology, Public Health, or a related field.
Minimum 10+ years of experience in the pharmaceutical, biotech, or scientific consulting industry focusing on COA strategy, psychometrics, and endpoint development.
Demonstrated mastery in designing qualitative and/or mixed methods protocols, analyzing complex qualitative/quantitative datasets, and base knowledge of modern psychometric methods.
Deep working knowledge of global regulatory guidelines (including FDA Patient-Focused Drug Development guidance).
Technical & Soft Skills Requirements
Communication: Exceptional writing skills; the ability to turn scientific jargon into clear, persuasive regulatory and patient facing narratives. Demonstrated cross-functional leadership, negotiation, and written/verbal communication skills.
Training: Ability to train and mentor long-term and new COA researchers in cross-functional evidence generation and synthesis.
Adaptability: Comfortable navigating and leading the presentation of the gray areas of emerging scientific methods where established regulations may not yet exist.
Project Management: Proven ability to manage multiple high-stakes deadlines simultaneously as a member of the company leadership team.
Team & Center of Excellence Oversight: Previous experience managing, mentoring, and building a high-performing team of qualitative and quantitative measurement scientists.
