Director, Commercial Legal Senior Counsel

Vertex Inc.•Boston, MA

4d•Hybrid

About The Position

As Director, Commercial Legal Senior Counsel – Genetic Kidney, you will play a pivotal role in Vertex’s highly respected Legal and Compliance Department, based at our global headquarters in Boston, MA. Our department thrives on trust, collaboration, and a shared commitment to growth and development. We value attorneys who bring thoughtful judgment, practical solutions, and a commitment to contributing to our culture, development initiatives, and pro bono efforts. The Director, Commercial Legal Senior Counsel – Genetic Kidney will provide strategic, practical legal counsel that helps shape commercialization priorities for Vertex’s U.S. and global Genetic Kidney teams. Reporting to the Senior Director, Assistant General Counsel, this role will serve as a trusted advisor that partners closely with key commercialization stakeholders, including Sales & Marketing, Medical Affairs, Field Training, Regulatory Advertising and Promotion, Public Affairs, Patient Advocacy, and Corporate Communications and serve on various review committees. The ideal candidate will have deep expertise in healthcare law, with a proven track record of advising on legal issues related to healthcare fraud and abuse law, advertising and promotion, scientific exchange, patient support, and interactions with healthcare professionals. This role requires a strategic thinker with exceptional communication skills and the ability to navigate complex regulatory frameworks while advancing business objectives. This is an opportunity to advise on evolving commercialization priorities across the product lifecycle, identify emerging risks and opportunities, and help shape practical legal strategies in a fast-paced, collaborative environment.

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, with the ability to convey complex legal concepts to diverse audiences and influence key stakeholders.
Strong analytical, problem-solving skills, with the ability to apply sound judgment and develop practical legal solutions.
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.

Nice To Haves

Demonstrate strong interpersonal skills, with the ability to build effective working relationships.
Apply sound business judgment and ethical decision-making, with a proactive and solutions-oriented approach.
Work effectively in a fast-paced, dynamic environment while managing multiple priorities.
Collaborate effectively with colleagues and value diversity and inclusion as important drivers of team success.
Embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends.
Bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Responsibilities

Serve as a trusted legal advisor to the 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 a range of business audiences.
Partner with U.S. Sales and Marketing, Global Commercial Strategy, Medical Affairs, Field Training, Regulatory Advertising and Promotion, Public Affairs, Patient Advocacy and Corporate Commutations.
Participate actively in communication, medical and label review committees ensuring 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.
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 judgement to identify, assess and mitigate legal and reputation risks.
Help safeguard Vertex’s integrity while enabling the business to meet commercialization objectives.