Director Clinical Outcomes Assessment

Essential Functions

• 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.

REQUIRED EDUCATION, EXPERIENCE and SKILLS

• 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-Centered 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.
• Able to operate effectively in a global matrix environment.

PREFERRED EDUCATION, EXPERIENCE AND SKILLS

• 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.

Pay & Benefits

Pay Range: $220,000 - $250,000
Eligibility for a 25% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan.
Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our site.