Director, Commercial Legal Senior Counsel

Overview

This role provides strategic, practical legal counsel to support commercialization priorities for U.S. and global Genetic Kidney teams. Reporting to the Senior Director, Assistant General Counsel, the Director, Commercial Legal Senior Counsel – Genetic Kidney serves as a trusted advisor to key commercialization stakeholders and participates in various review committees.

Responsibilities

Strategic Legal Counsel

• Serve as a trusted legal advisor to U.S. and global Genetic Kidney commercialization teams, providing strategic counsel on commercialization initiatives and business priorities.
• Provide practical, business-focused legal advice on advertising and promotion, scientific exchange, healthcare fraud and abuse, patient support, and other matters related to the commercialization of prescription drugs.
• Advise stakeholders on the interpretation and application of healthcare laws, regulations, agency guidance, and enforcement trends.
• Identify emerging legal risks and opportunities and recommend proactive, workable solutions that support compliant business execution.
• Translate complex legal and regulatory considerations into clear guidance for business audiences.

Cross-Functional Partnership and Governance

• Partner with U.S. Sales and Marketing, Global Commercial Strategy, Medical Affairs, Field Training, Regulatory Advertising and Promotion, Public Affairs, Patient Advocacy, and Corporate Communications.
• Participate in communication, medical, and label review committees to ensure compliance and alignment with business goals.
• Build productive working relationships with internal stakeholders to align legal strategies with business priorities.
• Contribute to department-wide initiatives, including culture-building and pro bono programs.

Risk Management and Compliance

• Provide counsel on healthcare laws, including the Food, Drug, and Cosmetic Act and associated regulations, anti-kickback statutes, the False Claims Act, and Lanham Act.
• Support compliant interactions with patients, caregivers, healthcare professionals, and other healthcare stakeholders.
• Apply sound judgment to identify, assess, and mitigate legal and reputation risks.
• Help safeguard integrity while enabling the business to meet commercialization objectives.

Requirements

• Experience supporting pre- and post-launch biopharmaceutical products.
• Demonstrated experience advising on healthcare regulatory and compliance matters, including advertising and promotion, healthcare fraud and abuse, patient support, scientific exchange, and interactions with healthcare stakeholders.
• Demonstrated ability to interpret and apply the Food, Drug, and Cosmetic Act, anti-kickback statutes, the False Claims Act, the Lanham Act, and related regulations and guidance.
• Experience advising communication review committees and providing guidance on FDA’s CFL, payor, and SIUU guidance.
• Strong communication skills, including the ability to convey complex legal concepts to diverse audiences and influence key stakeholders.
• Strong analytical and problem-solving skills, with the ability to apply sound judgment and develop practical legal solutions.

Education & Experience

• Juris Doctor (JD) degree from an ABA-accredited law school.
• Active membership in good standing with a state bar.
• At least 7+ years of post-JD experience in healthcare law within the biopharma company, law firm, or combination of both.

Preferred Qualifications

• Strong interpersonal skills, with the ability to build effective working relationships.
• Proactive, solutions-oriented approach with ethical decision-making and strong business judgment.
• Ability to work effectively in a fast-paced, dynamic environment while managing multiple priorities.
• Ability to collaborate effectively and value diversity and inclusion.

Compensation & Benefits

• Pay Range: $0 - $0
• This role is eligible for an annual bonus and annual equity awards.
• Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.
• Actual base salary pay will be based on skills, competencies, experience, and other job-related factors permitted by law.
• Total Rewards include medical, dental, and vision benefits; generous paid time off (including a week-long company shutdown in the Summer and the Winter); educational assistance programs including student loan repayment; a generous commuting subsidy; matching charitable donations; and 401(k), among other offerings.

Location & Flexibility

• Boston, MA (global headquarters).
• Remote-Eligible. Flex eligibility allows you to choose one of the following:
  • Remote: work remotely five days per week and come into the office on occasion (always welcome on-site), or select
  • Hybrid: work remotely up to two days per week, or select
  • On-Site: work five days per week on-site with ad hoc flexibility.
• Flex status is subject to the employer’s Flex program policy and may be changed at any time.