SUMMARYThe 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.
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-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.
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.
TRAVEL- Regular international travel required, including travel to Copenhagen, Denmark, approximately 4-6 times per year, in addition to occasional domestic and international travel for scientific conferences, regulatory meetings, and internal business activities (3-4 times per year).
The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $220,000 - $250,000 and 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. Applications accepted on an ongoing basis. #LI-LM1
