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 . Company Lundbeck is a global biopharmaceutical company specialized in brain diseases. We are dedicated to advancing brain health and transforming lives. To fulfill this purpose, Lundbeck is engaged in the research, development, manufacturing, and commercialization of pharmaceuticals across the world. For more than 70 years, Lundbeck has been at the forefront of neuroscience research. Our commitment is to empower patients to give them the tools and resources they need to understand their disease and its unfolding. Our commitment is to continuously challenge status quo and push our science further to make real differences for patients. Our commitment is to families to bring evidence-based data, visibility and support to their work in managing a chronic disease. Our commitment is to communities to end the stigma, fear, and silence that surrounds brain diseases. Our commitment is to society, to increase access to medicines for the most vulnerable, to act responsibly towards the environment and to behave with respect and integrity in everything we do.

Offices in:

Deerfield, IL

Lundbeck US Home Office La Jolla, CA
Lundbeck La Jolla Research Center, Inc. Bothell, WA
Lundbeck Seattle BioPharmaceuticals, Inc Company info Website https://www.

lundbeck.com/global Phone 224-507-1000 Location 6 Parkway North Deerfield Illinois 60015 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert Similar jobs Clinical Trial Manager Japan Clinical Engagement Lead

West / Midwest United States Senior Manager, Biostatistics Working from Home

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