Director Clinical Outcomes Assessment
About The Position
The Clinical Outcomes Assessments Director serves as a strategic scientific leader responsible for the development and execution of Clinical Outcomes Assessment (COA) strategies across assigned development programs. The role ensures that patient, caregiver, clinician, and observer perspectives are appropriately captured through fit-for-purpose outcome measures and that endpoint strategies are aligned with development objectives, regulatory expectations, and future value and differentiation demonstration needs. Based in the United States, this role serves as an important bridge between US and Global teams, helping ensure alignment of endpoint strategies globally.
Requirements
- PhD/PharmD/MD with 8+ years relevant experience OR Accredited Master's degree with 10+ years relevant experience.
- 8+ years in Clinical Outcomes Assessment, Patient-Centred Outcomes Research, or related pharmaceutical/biotech functions.
- 5+ years supporting regulatory interactions with FDA, EMA, or other health authorities including HTAs
- Strong communication, stakeholder management, analytical and problem-solving skills.
- Strong cross-functional collaboration skills.
- Ability to operate effectively in a global matrix environment.
Nice To Haves
- Experience in neuroscience and/or rare disease drug development.
- Experience with digital endpoints and innovative measurement technologies.
- Experience contributing to regulatory submissions and health authority meetings.
Responsibilities
- Lead the development and implementation of Clinical Outcomes Assessment strategies across assigned assets and development programs.
- Provide scientific leadership on the selection, development, adaptation, validation, implementation, and interpretation of PROs, ClinROs, ObsROs, and PerfOs.
- Ensure outcome measures are fit-for-purpose and aligned with external stakeholders’ requirements (regulatory, HTAs, physicians, patients and care partners).
- Provide strategic expertise on endpoint selection, endpoint justification and interpretation of results.
- Support interactions with FDA, EMA, and other health authorities including HTAs regarding endpoint selection and validation strategies.
- Contribute to regulatory and HTAs briefing documents and meeting preparations
- Partner with cross-functional R&D and Commercial representatives to support endpoint strategies.
- Support interactions with FDA, EMA, and other health authorities including HTAs
- Maintain awareness of evolving regulatory guidance and innovative measurement methodologies.
- Develop relationships with external experts, academic collaborators and patient advocacy organizations.
- Promote scientific excellence and innovation in patient-centred outcomes research.
- Contribute to scientific publications and conference presentations.
Benefits
- flexible paid time off (PTO)
- health benefits to include Medical, Dental and Vision
- company match 401k
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What This Job Offers
Job Type
Full-time
Career Level
Director
