Senior Counsel, Commercial Law

About the role

We are seeking an energetic, motivated attorney to join our team as Senior Counsel, Commercial Law. Reporting to the SVP, Commercial Law and Healthcare Compliance, you will provide strategic legal advice within a highly regulated environment to uniQure’s commercial, medical affairs, market access and reimbursement, and patient support functions in support of uniQure’s planned first launch in the United States.

This role will be responsible for providing hands-on, day-to-day legal support and advice, and business partnership on a wide range of strategic and tactical initiatives, including pre-launch activities, market access activities, patient support programs, materials review (advertising/promotion and medical/scientific communications), and government programs.

The ideal candidate will work cross-functionally with multiple departments, including Commercial, Medical, and Market Access, to identify opportunities to compliantly advance commercial business objectives, identify legal risks, and provide sound counsel to mitigate such risks. This involves close collaboration with internal business teams to ensure an understanding of their needs and to foster a trusted partnership around legal matters.

This role is best suited for a seasoned, versatile, and strategic lawyer with 10+ years of legal experience in pharmaceutical product development and commercialization who is looking for a role with meaningful opportunities for professional development. In-house experience at an early-stage pharmaceutical/biotech company is required, with experience supporting a company through its first launch preferred.

Responsibilities

• Partner with, and provide pragmatic and solutions-oriented legal advice and support to, rapidly growing Commercial and Medical Affairs organizations; identify and resolve critical legal and business issues associated with product launch and market entry and communicate those solutions clearly and concisely.
• Provide counsel on state and federal laws and regulations impacting commercial operations, including Anti-kickback Statute, False Claims Act, OIG Guidance, PhRMA Code, and state drug pricing transparency laws.
• Advise on a wide variety of matters related to:
  • Distribution, trade, and channel strategy across specialty pharmacies, distributors, wholesalers, GPOs, and PBMs;
  • Establishing compliant patient support programs;
  • Pricing, coverage, and reimbursement strategies under Medicare Parts B and D, Medicaid, and Veterans Health Care Act;
  • Government pricing matters, such as requirements and compliance with Medicaid Drug Rebate Programs (MDRPs), including impact to Average Manufacturer Price, Best Price, and other price reporting calculations, and PHS 340B program;
  • Federal Supply Schedule (FSS) contract, including annual negotiation of FSS prices and reporting in compliance with Federal Acquisition Regulations (FARs) and the Veterans Health Care Act.
• Advise on promotional, medical, training, and disease awareness materials for compliance with applicable laws and regulations by participating as Legal reviewer on promotional and medical materials review committees.
• Assist with government price reporting audits and related processes.
• Draft, review, and negotiate business agreements, including those with vendors, healthcare professionals, centers of excellence, specialty pharmacies, patient support vendors, payor agreements, distributor, GPO and wholesaler agreements, and sponsorship, grant, and charitable contribution arrangements. Ensure all agreements comply with applicable healthcare laws, internal policies, and government pricing requirements.
• Partner effectively with the broader Legal/Compliance team and with internal clients as a trusted strategic business partner.
• Develop and conduct policies and training, including periodic updates, for internal teams on relevant topics and legal developments; play a key role in building and driving a culture of compliance throughout the organization.
• As a member of the Commercial Legal Team, actively contribute to the legal function by building a positive culture, fostering engagement, sharing best practices, and participating in initiatives focused on building departmental and functional knowledge and competencies.

Requirements

• J.D. from an accredited law school and member in good standing of the Massachusetts bar.
• A minimum of ten years of experience within the biotech, pharmaceutical, or life sciences industry and in-depth knowledge of product development, U.S. commercial, compliance, and regulatory matters related to the launch and subsequent commercialization in the U.S. of branded pharmaceutical products.
• Experience with trade, distribution, and market access contracting (including payer, formulary, specialty pharmacy, etc.) is a plus.
• Thorough understanding of healthcare laws and regulations related to commercialization and launch of biopharmaceutical products in the U.S. and preferably ex-U.S. as well, including False Claims Act, the Anti-Kickback Statute, OIG guidelines and opinions, the Sunshine Act, FCPA, fraud and abuse, transparency and other healthcare compliance matters, pricing laws and implications, and commercial launch strategies.

Skills

• Pragmatic, agile mindset with the ability to manage multiple tasks and timelines in a fast-paced environment with attention to quality and detail.
• Ability to cultivate strong stakeholder relationships and successfully influence leadership and peers with tact, diplomacy, and professionalism.
• Commitment to collaboration, professionalism, and ethical conduct, including the ability to handle confidential and/or sensitive information.
• Excellent verbal and written skills, allowing for open and effective dialogue throughout the company.

Schedule

This is a hybrid position. The company is located in Lexington, MA, and requires onsite presence 3 days per week. Some travel may be required, including to the company’s other sites located in Amsterdam, The Netherlands, and Basel, Switzerland.

Pay

The salary range for this position is $275,000 to $332,000. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant, relevant years of experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from where they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.