Director, Patient Centered Outcomes Research
$172,000–$258,000 year
HybridBillerica, Massachusetts, United States
Job Summary
Lead development and execution of patient-focused evidence strategies for assigned programs, including designing, executing, and delivering non-interventional studies to generate regulatory-grade Patient Experience Data. Develop conceptual models and validate clinical outcome assessment measures for studies, ensuring integration of patient-experience considerations into program-level planning and regulatory submissions. Serve as a subject matter expert on qualitative, quantitative, and mixed-methods methodologies, representing the company in cross-functional governance bodies and scientific forums. Build partnerships with academic institutions, patient advocacy groups, and clinical investigators while managing project-related contracting and vendor relationships. Ensure deliverables meet regulatory guidelines and internal quality standards. Location: Hybrid (3x/week) in Billerica, MA.
Required Qualifications
- Master's degree (or higher) in socio-behavioral sciences, health outcomes measurement, psychology, behavioral sciences, ethnography, psychometrics, or related field
- 10+ years in patient-centered research, patient-focused drug development, or outcomes research in the Pharmaceutical/Biotech industry
- Strong understanding of clinical drug development and lifecycle management
- Demonstrable experience supporting key phases of a clinical program (e.g., initiation of Phase 3, regulatory filing)
- Deep understanding of PFDD guidance and regulatory expectations on PFE and COA measurement, internationally (including FDA, EMA, Chinese FDA)
- Demonstrable experience and knowledge of designing and implementing PED studies – applying qualitative, quantitative, and mixed-methods
- Demonstrable expertise in developing and validating COA measures
- Demonstrable experience contributing to COA/PED-related aspects in regulatory engagements and submissions
Desired Qualifications
- Doctoral degree (PhD, MD) in socio-behavioral sciences or related field
- Proven ability to influence stakeholders and operate effectively in a matrixed, cross-functional environment without direct authority
- Strong conceptual, methodological, and analytical skills
- Curious, innovative, and solution-focused mentality
- Excellent scientific communication skills with ability to translate complex technical concepts into clear, actionable recommendations for diverse audiences
- Ability to work effectively in ambiguity and navigate complex stakeholder environments
- Collaborative mindset with ability to build trust across functions and with external partners
- Demonstrable ability to integrate AI tools in daily scientific work
- Experience across multiple therapeutic areas
- Familiarity with digital health technologies and wearable devices
- Experience applying novel methodologies in evidence planning and generation
- Emerging track record of scientific contributions in PFE (publications, conference presentations)
- Experience with FDA/EMA COA qualification processes
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