Senior Director, Commercial Legal Affairs

Who We Are
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.
Key ResponsibilitiesStrategic 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 economic and outcomes information
Disease awareness and unbranded communications
External communications regarding clinical and scientific data
Market Access, Pricing, and Contracting
Provide legal counsel on market access and reimbursement strategies.
Advise on:
Government pricing requirements and reporting obligations
Medicaid, Medicare, 340B, Veterans Health Care Act, and related programs
State and federal pricing transparency requirements
Market access promotional considerations
HEOR and value communications
Support the development, negotiation, interpretation, and administration of customer contracts involving:
Commercial and government payers
Pharmacy Benefit Managers (PBMs)
Group Purchasing Organizations (GPOs)
Specialty pharmacies and specialty distributors
Wholesalers and distribution partners
Integrated Delivery Networks (IDNs)
Healthcare providers and health systems
Patient services vendors
Review and negotiate rebate agreements, value-based arrangements, administrative service agreements, distribution agreements, data agreements, and other commercial contracting arrangements.
Healthcare Compliance and Fraud & Abuse
Advise on compliance with federal and state healthcare laws and regulations, including:
Federal Anti-Kickback Statute
False Claims Act
Government pricing and reimbursement requirements
OIG guidance and advisory opinions
State healthcare compliance requirements
PhRMA Code
Support internal investigations, risk assessments, audits, and compliance initiatives as needed.
Patient Support Programs and Advocacy
Counsel business partners on the design, operation, and compliance of patient support and patient assistance programs.
Advise on interactions and collaborations with patient advocacy organizations and related stakeholders.
Provide guidance regarding grants, sponsorships, educational support, and patient engagement activities.
Antitrust, Competition, and Product Liability
Advise on antitrust and competition law issues arising from commercial strategy, contracting, pricing, market access activities, and interactions with competitors, customers, and trade associations.
Partner with internal stakeholders and outside counsel on product liability matters, litigation-related risk assessments, and response strategies.
Support legal oversight of commercial practices and commercial policies to mitigate litigation and enforcement risks.
Cross-Functional Collaboration and Leadership
Collaborate closely with Compliance, Regulatory, Medical Affairs, Corporate Affairs, Government Affairs, and other Legal colleagues to deliver coordinated legal support.
Manage external counsel effectively and responsibly.
Stay informed regarding evolving legal, regulatory, and enforcement developments affecting the biopharmaceutical industry.
Contribute to Legal & Compliance Department initiatives, team development, training, and knowledge-sharing efforts.
Serve as a trusted advisor to senior leadership and provide leadership within the Legal & Compliance organization.
Qualifications, Professional Skills, and Preferred Experience
JD from an ABA-accredited law school.
Active membership in at least one state bar.
Minimum of 12 years of post-JD legal experience, including significant experience in the biopharmaceutical, pharmaceutical, biotechnology, medical device, or life sciences industry, either in-house, at a law firm, or both.
Significant experience supporting commercial pharmaceutical operations and product commercialization.
Demonstrated expertise advising on:
FDA advertising and promotion requirements
Commercial and brand strategy
Healthcare fraud and abuse laws
False Claims Act considerations
Market access and reimbursement
Government pricing
Patient support and assistance programs
Antitrust and competition law
Commercial contracting
Product liability and risk management
Deep understanding of laws, regulations, and guidance applicable to commercial pharmaceutical activities, including FDA regulations, Medicare, Medicaid, 340B, Anti-Kickback Statute, False Claims Act, state healthcare laws, pricing transparency laws, OIG guidance, and PhRMA Code requirements.
Significant experience reviewing, drafting, negotiating, and counseling on a broad range of commercial agreements, including payer, distribution, patient services, data, and services arrangements.
Strong judgment and ability to provide practical, business-focused legal advice in a dynamic and highly regulated env