Director, Patient-Centered Outcomes Strategy

Merck & Co.; Deerfield (IL); On-site; USD 220,000 - 250,000; Full time

Benefits offered by this job

Flexible PTO

Health benefits (Medical, Dental, VIsn

Job summary

Lundbeck is a global biopharmaceutical company focusing on brain health and is seeking a Clinical Outcomes Assessments Director based in the United States. You will lead COA strategies across development programs and ensure patient perspectives are captured through fit-for-purpose measures aligned with regulatory expectations.

You will provide scientific leadership for PROs, ClinROs, ObsROs and PerfOs, interact with FDA/EMA, collaborate across global teams, and contribute to regulatory

Qualifications

• PhD/PharmD/MD with 8+ years relevant experience or Accredited Master's with 10+ years.
• 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 and ability to operate in a global matrix.

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.

Skills

Clinical Outcomes Assessment

Regulatory interactions

Cross-functional collaboration

Global matrix environment

Communication skills

Education

PhD/PharmD/MD with 8+ years relevant experience

Accredited Master's degree with 10+ years relevant experience

Job description

Lundbeck is a global biopharmaceutical company focusing on brain health and is seeking a Clinical Outcomes Assessments Director based in the United States. You will lead COA strategies across development programs and ensure patient perspectives are captured through fit-for-purpose measures aligned with regulatory expectations.

You will provide scientific leadership for PROs, ClinROs, ObsROs and PerfOs, interact with FDA/EMA, collaborate across global teams, and contribute to regulatory