Associate Director US Legal Affairs and Corporate Counsel

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 Associate Director, Legal Affairs serves as a strategic, solution-oriented business partner, building strong stakeholder relationships across the organization while helping enable business objectives through practical legal guidance and sound risk management. This role partners with assigned business leaders to navigate complex legal, regulatory, and operational issues across a broad range of commercial, technology, and healthcare matters. The Associate Director helps shape legal strategies that support business strategy, innovation, emerging technologies, commercial initiatives, patient-focused programs, and strategic collaborations while protecting the company's interests and ensuring compliance with applicable laws and regulations.

Essential Functions:

Strategic Legal Business Partnership

- Serve as a trusted legal advisor and strategic business partner to assigned leaders across the organization, helping shape business decisions through practical, solution-oriented legal counsel.

- Partner with cross-functional stakeholders to navigate complex legal and regulatory issues while enabling strategic business objectives.

- Influence informed decision-making by identifying legal risks, evaluating alternatives, and developing balanced, business-focused solutions.

- Contribute to enterprise initiatives by integrating legal considerations into business planning, operational execution, and innovation efforts.

Product Commercialization and Launch Support

- Serve as a strategic legal advisor to U.S. business functions, including Marketing, Medical Affairs, and Regulatory Affairs, providing legal counsel and guiding risk-based decision-making related to marketed pharmaceutical products, pipeline assets, and commercialization activities. Provide strategic counsel on FDA regulations, the False Claims Act, the Anti-Kickback Statute, OIG guidance, the PhRMA Code, the Sunshine Act, privacy and data security laws and regulations, and competition law in connection with product labeling, promotional and non-promotional activities, marketing strategies, sales activities and compensation, pharmacovigilance, medical information, scientific exchange, and interactions with healthcare professionals.

- Advise on clinical development and commercialization of pipeline assets, including pre-launch activities and launch planning; partner with Medical Affairs, Commercial, Market Access, and Regulatory teams to support compliant launch execution, scientific exchange, and stakeholder engagement.

- Provide legal leadership and guidance on advertising, promotional, marketing, educational, and other external communications, advising cross-functional stakeholders on regulatory compliance, legal risks, and appropriate business solutions. Monitor significant pending and actual decisions, legislation, and regulatory rulings affecting commercial healthcare law and supported business areas, and communicate their implications to relevant stakeholders.

- Maintain awareness of the intellectual property status of the company's strategic brands and liaise with the Intellectual Property team.

Healthcare Legal Counseling

- Counsel stakeholders on complex legal issues involving, patient and caregiver engagement, commercial activities, and other healthcare-related initiatives.

- Guide the development of compliant, patient-centered solutions that align with applicable laws, regulations, and company policies;

- Support the development and implementation of compliance frameworks, policies, and training tailored to rare disease commercialization and patient and caregiver engagement.

- Navigate legal and regulatory considerations affecting healthcare operations while supporting innovative business initiatives.

Stakeholder Engagement and Enterprise Influence

- Cultivate strong relationships across Legal, Compliance, Commercial, Medical Affairs, Regulatory Affairs, Market Access, Research & Development, Information Technology, Finance, and other business functions.

- Influence outcomes through sound judgment, credibility, collaboration, effective communication, negotiation skills, and legal expertise.

- Translate complex legal concepts into practical business guidance and effectively communicate legal issues and risks to internal and external stakeholders, including operational management and C-suite executives.

- Champion practical legal solutions that enable innovation while maintaining appropriate legal and regulatory safeguards.

- Collaborate with Global Legal, Regulatory and Compliance teams to align U.S. strategies with enterprise goals and support legal and regulatory compliance for global activities involving U.S. stakeholders or events.

- Serve as the legal representative on business and operational committees and as a resource to colleagues in areas of subject matter expertise, supporting a collaborative working environment.

- Contribute to the continuous improvement of legal processes, contract templates, governance frameworks, and best practices that enhance organizational effectiveness and risk management.

Outside Counsel and General Counsel Support

- Partner with and provide direction to outside legal counsel, as appropriate, on complex legal matters, regulatory developments, commercial activities, and other business priorities, ensuring effective legal support and management of associated risks.

- Provide legal counsel and support to the General Counsel on strategic initiatives, complex legal matters, and internal or external investigations, as assigned.

REQUIRED EDUCATION, EXPERIENCE AND SKILLS

- Juris Doctor (JD) degree from an ABA-accredited law school.

- Admission to the Massachusetts Bar, or eligibility and willingness to obtain admission.

- Seven (7) or more years as attorney/counsel, including at least two (2) years with a law firm.

- Experience providing general corporate and/or commercial legal counsel, either in-house or in private practice, within the pharmaceutical, biotechnology, medical device, or other highly regulated industries...

- Knowledge of FDA drug and biologic law, the False Claims Act, the Anti-Kickback Statute, OIG guidance, the PhRMA Code, the Sunshine Act, the Foreign Corrupt Practices Act, competition law, and U.S. pharmaceutical regulations.

- Excellent oral and written communication and interpersonal skills, including the ability to present legal guidance effectively to all levels of the company, from operational management to C-suite executives.

- Ability to manage multiple projects, meet deadlines, and communicate effectively with colleagues and employees at all levels.

- High degree of personal, professional, and corporate ethics, integrity, and responsibility.

PREFERRED EDUCATION, EXPERIENCE AND SKILLS

- Litigation experience.

- Knowledge of international law relevant to the industry.

- Experience supporting commercial function in the pharmaceutical, biotechnology, or medical device industry

- Experience supporting advertising and promotional review.

- Knowledge of or experience in rare disease.

TRAVEL

Willingness and ability to travel up to 10% domestically. International travel may also be required

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 .