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$144k–$198k/yr
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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…
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$220k–$250k/yr
Full-time
postgraduate degree
Flexible paid time off (PTO), Medical insurance, Dental insurance, Vision insurance, 401k company match, Bonus target
Posted 22h ago
~40 hrs/week
Responsibilities
The Director leads the development and execution of Clinical Outcomes Assessment (COA) strategies to capture patient and clinician perspectives across development programs. This includes providing scientific leadership on endpoint selection and managing interactions with global regulatory authorities and health technology assessments.
Requirements
Requires a PhD, PharmD, or MD with 8+ years of experience, or a Master's degree with 10+ years of experience in COA or patient-centered outcomes research. Candidates must have at least 5 years of experience supporting regulatory interactions with agencies like the FDA and EMA.
Full 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. 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
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.
Lundbeck is a 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.
Brain disorders affect a large part of the world’s population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments.
As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole.
Lundbeck has more than 5,000 employees in more than 20 countries and our products are available in more than 80 countries.
For additional information, we encourage you to visit our corporate site www.lundbeck.com
Offices: H. Lundbeck, Ottiliavej 9, Valby, Copenhagen 2500, DK
Neuroscience researchSchizophreniaPsychosisParkinson's diseaseAlzheimer's diseaseDepressionMental HealthPsychiatryNeurologyBrain Health
How much do Management & Leadership jobs in Deerfield, IL pay?
Based on 104 listings with disclosed salaries, most management & leadership jobs in Deerfield, IL pay between $70k–$205k per year. Individual offers vary with seniority, company size, and specialization.
How many Management & Leadership jobs are open in Deerfield, IL right now?
There are currently 123 open management & leadership positions in Deerfield, IL listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Management & Leadership roles in Deerfield, IL?
Companies currently hiring include Fortune Brands Innovations, Baxter International Inc., Vantive, Lundbeck, Hunkemöller, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Management & Leadership jobs in Deerfield, IL?
Yes — 67 of the 123 open management & leadership positions offer remote or hybrid work (15 remote, 52 hybrid).
How do I apply for Management & Leadership jobs in Deerfield, IL?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.