Director Clinical Outcomes Assessment

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

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!

SUMMARY

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.

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.

• flexible paid time off (PTO)
• health benefits to include Medical, Dental and Vision
• company match 401k

Additional benefits information can be found on our site. Applications accepted on an ongoing basis. #LI-LM1

Why Lundbeck

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.

Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.

Lundbeck is proud to be an equal opportunity workplace.

We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation.

Lundbeck participates in E-Verify.

About Lundbeck

At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.

Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

The brain health challenge is real. Our commitment is real. Our impact is real.

About Lundbeck

At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.

Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

The brain health challenge is real. Our commitment is real. Our impact is real.