Senior Director, Commercial Legal Affairs

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions. Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world. About Corporate Groups It takes a village, and at BioMarin, our general and admin teams are the village behind our success. From the IT experts who manage our technology to the human resources professionals who hire the people who make it all possible, these teams support our organization and span all areas of operations. Senior Director, Commercial Legal Affairs Job Summary The Senior Director, Commercial Legal Affairs serves as a strategic legal partner to BioMarin's U.S. Commercial organization, providing practical, risk-based legal counsel across the full spectrum of commercial activities within a highly regulated environment. This role supports commercial functions including Marketing, Market Access, Pricing, Patient Services, Medical Affairs, Advocacy, Commercial Operations, Business Insights, and related functions. The successful candidate will advise on a broad range of legal, regulatory, and compliance matters, including promotional and advertising activities, FDA regulatory requirements, product commercialization, market access and reimbursement, payer contracting, antitrust, product liability, patient support programs, healthcare fraud and abuse laws, False Claims Act risk, advocacy engagement, privacy considerations, and business development initiatives. This individual will collaborate closely with business leaders and cross-functional partners to advance BioMarin's strategic objectives while protecting the company's integrity, reputation, and commitment to patients.

Strategic Commercial Counseling Serve as the lead legal advisor for U.S. Commercial functions, providing practical, business-oriented legal counsel that enables strategic decision-making while appropriately managing legal and reputational risk. Partner with commercial leadership to develop and implement business strategies consistent with applicable legal, regulatory, and compliance requirements. Advise on product launches, lifecycle management, commercialization strategies, market development initiatives, and portfolio planning. Advertising, Promotion, and Medical Legal Review Work with cross-functional colleagues to optimize the Medical, Legal, and Regulatory (MLR) review process, ensuring that responsibilities are appropriately allocated among stakeholders and that the process is scalable across products and geographies. Provide legal advice regarding prescription drug advertising and promotion, including compliance with FDA requirements, guidance, enforcement trends, and industry standards. Participate in Medical, Legal, and Regulatory (MLR) review processes. Review and counsel on: Promotional materials and campaigns Product claims and comparative claims Digital and social media communications Speaker programs and educational initiatives Scientific exchange activities Health