Medical Affairs Director - Rare Epilepsies

Lundbeck LLC; Boston (MA); Vor Ort; USD 260.000 - 290.000; Vollzeit

Zusammenfassung

Lundbeck LLC, a global biopharmaceutical company focused on brain health, seeks a Medical Affairs Director for Rare Epilepsies to lead US medical strategy related to DEE and bexicaserin. This role drives launch readiness, evidence generation, external engagement, and scientific communication across cross-functional teams.

You will partner with HEOR, Commercial, Regulatory, Clinical Development, Compliance and others to ensure scientifically rigorous, compliant programs and impactful medical

Qualifikationen

• Accredited advanced scientific or clinical degree (MD, PharmD, PhD or MS).
• 5+ years of progressive, non-field-based Medical Affairs experience in pharma/biotech.
• Minimum 2+ years contributing to medical strategy, launch readiness, evidence generation.

Aufgaben

• Provide medical leadership across DEE and bexicaserin US launch readiness.
• Lead cross-functional medical strategy, education, publication and congress planning.
• Engage with investigators, KOLs, advocacy groups and healthcare professionals.
• Synthesize external insights to inform US and global medical strategies.
• Co-create with Global Medical Affairs to ensure US insights inform messaging and data stories.
• Serve as medical reviewer in promotional review processes.

Kenntnisse

Medical Affairs

Launch readiness

External engagement

Scientific communications

Regulatory knowledge

Evidence generation

Ausbildung

MD/PhD/PharmD/MS

Jobbeschreibung

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 Medical Affairs Director - Rare Epilepsies will provide strategic medical leadership for developmental and epileptic encephalopathies (DEE) and bexicaserin, supporting U.S. launch readiness and execution across the U.S. Medical Affairs organization. This role will shape and advance the U.S. medical strategy by integrating scientific evidence, external stakeholder insights, cross-functional partnership, and high-quality medical execution to address the needs of people living with DEE, families, caregivers, healthcare professionals, payers, and policymakers.

The role will lead and contribute across medical strategy, launch readiness, evidence generation and dissemination, external expert engagement, medical education, publication and congress planning, scientific content development, promotional medical review, vendor management, budget oversight, and compliance review. This individual will partner closely with HEOR, Commercial, Customer Insights & Analytics, Patient Advocacy, Clinical Development, Compliance, Legal, Medical Affairs Operations, and Medical Affairs teams and external experts to ensure medical initiatives are scientifically rigorous, strategically aligned, compliant, and responsive to the evolving needs of the MSA community.

This leader will drive cross-functional alignment, scientific excellence, external engagement, and execution of the U.S. medical strategy, while elevating Lundbeck's presence and credibility within the DEE and rare epilepsy communities.

KEY RESPONSIBILITIES

Strategic Cross-Functional Partnership & Launch Readiness

• Provide expert medical perspective to co-create launch strategy together with Commercial, Patient advocacy, Market Access, Regulatory, Clinical Development, Pharmacovigilance, and other internal stakeholders.
• Partner cross-functionally to drive US medical launch readiness, lifecycle management.
• Translate clinical data and scientific insights into actionable strategies that inform stakeholder engagement and brand planning. In DEE, prioritize unmet needs, earlier recognition and diagnosis, meaningful seizure outcomes, and evidence needs relevant to patients and families.

External Engagement & Scientific Leadership

• Build and maintain strong, trusted relationships with investigators, key opinion leaders (KOLs), advocacy leaders, and healthcare professionals. Engage pediatric and adult epileptologists, neurologists, multidisciplinary care teams, and DEE patient advocacy organizations.
• Represent U.S. Medical Affairs in scientific forums and stakeholder engagements to reinforce Lundbeck’s scientific leadership in DEE and rare epilepsies.
• Synthesize external insights and monitor evolving DEE science, diagnostic and treatment practices, competitor activities, and policy landscape to proactively inform U.S. and global strategies.
• Lead and support relevant advisory board and insights strategy

Medical Strategy, Education and Scientific Communications

• Develop and execute U.S. medical education and scientific communications initiatives aligned to overarching brand and development objectives, with measurable impact.
• Co-create with Global Medical Affairs to ensure US insights inform the scientific narrative, clinical value story, lexicon, data story, key messages, evidence summaries, and communication themes.
• Ensure consistent, accurate, and balanced scientific communication of clinical data across materials.
• Interpret bexicaserin data to inform medical strategy and scientific exchange
• Develop and execute US-specific publication strategy and priorities; ensure alignment and integration with global publication plans.
• Develop and execute US medical congress strategy and execution, including data dissemination and key congress activities.
• Partner with Field Medical to inform field medical strategy, support scientific readiness, training, and consistent, compliant communication of the DEE and bexicaserin scientific narrative, and oversee development of necessary scientific resources.
• Serve as medical reviewer within the promotional review process, upholding the highest standards of scientific integrity and compliance.
• Designing and execute strategic Medical Education programs (CME and non-CME).
• Manage external partners and vendors, budgets, timelines, and deliverables.

Evidence Generation & Scientific Data Strategy

• Identify and prioritize critical US evidence gaps and translate unmet medical needs, scientific insights, and stakeholder perspectives into a strategic evidence generation and scientific communication roadmap.
• Implement US evidence generation initiatives, including post hoc analyses, real-world evidence studies, observational research, and investigator-initiated studies, ensuring scientific rigor and decision-relevant objectives.
• Partner with Global Medical Affairs, Clinical Development, HEOR, and cross-functional stakeholders to align research priorities, optimize evidence generation investments, and ensure complementary evidence plans.
• Ensure evidence generation outputs inform medical strategy, scientific exchange, clinical practice, and future research priorities, maximizing the scientific and strategic value of generated data.

REQUIRED EDUCATION, EXPERIENCE, AND SKILLS

• Accredited advanced scientific or clinical degree (MD, PharmD, PhD or MS).
• 5+ years of progressive, non-field-based Medical Affairs experience within pharmaceutical or biotech industry or at an agency that supports the pharmaceutical or biotech industry.
• Minimum 2+ years contributing to medical strategy development, launch readiness, evidence generation, external engagement, and medical education.
• Demonstrated experience designing and executing Medical Education programs (CME and non-CME).
• Experience developing and executing evidence generation strategy
• Strong understanding of clinical trial data, evidence generation, publication practices, and therapeutic-area strategy and translate insights into strategic recommendations.
• Experience translating scientific evidence and stakeholder insights into medical strategy, education, and communication priorities.
• Knowledge of compliance requirements, publication ethics, and medical/legal/regulatory review processes.
• Experience serving as a medical reviewer for promotional materials, ensuring compliance and scientific rigor.
• Strong analytical thinking, problem-solving capability, and data-driven decision-making skills.
• Demonstrated success building collaborative cross-functional relationships and influencing without authority.
• Experience managing multiple priorities in a dynamic environment.
• Exceptional communication skills with ability to convey complex scientific information clearly and persuasively.
• Demonstrated integrity, professionalism, and commitment to ethical standards.

Rare Disease Capabilities and Leadership

• Authentic, long-term engagement within the rare disease community, viewed as a trusted and mission-driven partner.
• Demonstrated ability to collaborate respectfully and effectively with patient advocacy groups (PAGs), patients, caregivers, clinicians, and industry stakeholders.
• Deep understanding of rare disease best practices, access and policy considerations, and patient support ecosystems.
• Ability to build relationships with rare disease clinical leaders, scientific societies, and relevant patient organizations.
• Strong business acumen and strategic judgment, with the ability to communicate effectively with leadership and other cross functional stakeholders.
• Highly proactive and adaptable leader capable of operating effectively in evolving, data-limited environments.

PREFERRED EDUCATION, EXPERIENCE, AND SKILLS

• 8+ years of rare disease industry experience including preparing for and launching a rare neurology treatment.
• Neurologist, epileptologist, or pediatric neurologist with established relationships within the epilepsy/DEE KOL and patient advocacy communities.
• FDA regulatory knowledge.
• Strong preference for candidate to based in Deerfield, IL office

TRAVEL

• Willingness/ability to travel up to 35% domestically. Occasional international travel may be required.
• If based remotely, additional travel will be required to Deerfield, IL to meet the needs of the role and the business.

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: $260,000 - $290,000 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.