Senior Director, Legal, Corporate Counsel, Market Access (San Rafael)

DescriptionWho 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.This role provides expert Legal advice to the business on a wide range of activities within a highly regulated environment. This role is responsible for providing legal support to the Market Access function within BioMarin, including Pricing, Access, Value, and Evidence which supports, Managed Markets, Pricing, Government Pricing, Patient Support and related functions. The ideal candidate will have prior experience counseling prescription drug companies on legal issues relating to market access, government pricing, contracting, federal and state laws impacting pricing and access, antitrust, state pricing transparency patient assistance, brand strategy and product commercialization activities.Key ResponsibilitiesAdvise business partners on various Commercial initiatives in a way that advances the company’s strategy while addressing legal risks and protecting the company’s integrity and reputationProvide legal advice and counsel on:Statutory and regulatory obligations under Medicaid, Medicare, 340B program, Veterans Health Care ActMarket access and reimbursement issuesGovernment pricing, including price reporting compliance policies and reasonable assumptions documentsCenters for Medicare and Medicaid final rules and correspondence including letters and public comments on proposed rules and guidanceProposed and enacted United States federal and state legislation impacting pharmaceutical companies relating to market access, pricing, reimbursement as well as state drug price reporting and transparency laws and complianceServices and contracting relating to specialty distributors and specialty pharmaciesData and special projectsBrand strategic planning and business operation plansStaying abreast of evolving healthcare legislation and regulations and the enforcement landscapeProvide legal counsel and strategic support for the development, negotiation, interpretation, and administration of a broad range of pharmaceutical commercial contracts and arrangements with customers including:Commercial and government payersPharmacy Benefit Managers (PBMs)Group Purchasing Organizations (GPOs)Specialty pharmacies and distributorsWholesalers and distribution partnersIntegrated Delivery Networks (IDNs)Health systems and provider organizationsPatient support and patient services vendorsReview, draft, and negotiate rebate agreements, value-based and outcomes-based agreements, administrative service agreements, distribution agreements, data licensing agreements, patient support agreements, and other market access-related contracts.Ensure compliance with applicable laws and company policies, including Anti-kickback Statute and other US healthcare compliance laws and regulationsCollaborate with Legal and Compliance colleagues to ensure delivery of comprehensive legal adviceParticipate in Medical Legal Review to provide guidance regarding external messagingReview and counsel on product labeling, promotional claims, comparative claims, health economic information, scientific exchange activities, and communications regarding clinical data, as necessaryContribute to the Legal & Compliance DepartmentParticipate in various Legal & Compliance Department projects and initiatives, including committees such as Culture and Pro Bono & CommunityShare information and knowledge through group presentations and individual discussions with peers and managersQualifications, Professional Skills, and Preferred ExperienceJD from an ABA accredited law schoolMember of a state barMinimum of 8 years post-JD experience advising on legal matters in a life sciences space, whether in a law firm or in-house in the biopharmaceutical industry, or bothGovernment price reporting experienceFamiliarity with health economic and outcomes research (HEOR), value communications, and market access promotional considerations is preferred.Strong ability to provide practical, business-oriented legal advice in a highly regulated environment while balancing legal, regulatory, reputational, and commercial considerations.Experience advising on statutes, regulations, and guidance documents applicable to market access activities, including Medicaid, 340B program, Veterans Administration, federal and state anti-kickback statutes, state drug pricing transparency laws, OIG guidance documents and advisory opinions, the False Claims Act, and the PhRMA CodeSignificant experience advising on pharmaceutical customer contracting across a broad range of stakeholders, including commercial and government payers, Pharmacy Benefit Managers (PBMs), Group Purchasing Organizations (GPOs), specialty pharmacies, specialty distributors, wholesalers, Integrated Delivery Networks (IDNs), and healthcare providers.Demonstrated experience drafting, reviewing, negotiating, and counseling on complex market access, rebate, distribution, administrative services, data, patient support, and value-based contracting arrangements.Outstanding ability to effectively communicate (verbally and in writing), sound legal advice to lawyers and non-lawyers alike, coupled with a strong understanding of business needsExcellent analytical, problem-solving and organizational skills to handle multiple responsibilities simultaneously and still meet high quality and timeliness standardsAbility to effectively and efficiently manage outside counsel and adhere to a budgetExperience providing legal advice on specialty medicines is highly desiredEnjoys working collaboratively and cross-functionally on teams, as well as independentlyProactively solves problems and makes decisions with integrity and ethicsThrives in a fast-paced and dynamic environmentIs eager to take on new challengesNote: 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.