Job Description

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 Responsibilities

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 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 environment.
• Outstanding written and verbal communication skills, with the ability to effectively communicate complex legal concepts to both legal and non-legal audiences.
• Excellent analytical, strategic thinking, problem-solving, and organizational skills.
• Ability to manage multiple high-priority matters while maintaining exceptional quality and responsiveness.
• Demonstrated success influencing senior leaders and operating effectively in a matrixed organization.
• Strong people leadership, collaboration, and stakeholder management skills.
• Experience supporting specialty medicines and rare disease products is highly desirable.
• Demonstrated commitment to integrity, ethics, patient focus, and BioMarin's values.
• Thrives in a fast-paced, collaborative, and evolving environment and is eager to take on new challenges.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.