Senior Director, Legal, Corporate Counsel, Market Access

Description

Who We Are
Bio Marin 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 Bio Marin 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 Bio Marin, 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 Bio Marin, 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.

• Advise 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 reputation
• Provide legal advice and counsel on:
  • Statutory and regulatory obligations under Medicaid, Medicare, 340B program, Veterans Health Care Act
  • Market access and reimbursement issues
  • Government pricing, including price reporting compliance policies and reasonable assumptions documents
  • Centers for Medicare and Medicaid final rules and correspondence including letters and public comments on proposed rules and guidance
  • Proposed 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 compliance
  • Services and contracting relating to specialty distributors and specialty pharmacies
  • Data and special projects
  • Brand strategic planning and business operation plans
  • Staying abreast of evolving healthcare legislation and regulations and the enforcement landscape
• Provide 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 payers
  • Pharmacy Benefit Managers (PBMs)
  • Group Purchasing Organizations (GPOs)
  • Specialty pharmacies and distributors
  • Wholesalers and distribution partners
  • Integrated Delivery Networks (IDNs)
  • Health systems and provider organizations
  • Patient support and patient services vendors
• Review, 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…