Senior Director, Commercial Assistant General Counsel - Pain

Job Description

Why Join Us?

At Vertex, we are a transformative biotechnology company dedicated to creating new possibilities in medicine to improve lives. With five transformative medicines for cystic fibrosis, a pioneering gene therapy for sickle cell disease and transfusion-dependent -thalassemia, and a first-in-class non-opioid therapy for moderate to severe acute pain, we are at the forefront of healthcare innovation. Our robust pipeline and commitment to investing billions in R&D over the past two decades reflect our mission to transform the treatment of serious diseases.

As Senior Director, Assistant General Counsel - Pain, 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 work closely with business partners to deliver impactful results for our company and, most importantly, for the patients we serve.

Job Summary

The Senior Director, Assistant General Counsel - Pain will serve as a senior representative, enterprise thought partner and advisor to Vertex's U.S Business Unit Leadership Team as well as the Pain Disease Strategy and Global Commercialization Pain teams, providing expert guidance on complex legal and regulatory matters in a dynamic and highly regulated environment. Reporting to the VP, Commercial and Development Legal, this role will also support cross-functional teams, including Sales & Marketing, Medical Affairs, Field Training, Regulatory Affairs, Public Affairs, Patient Advocacy, and Corporate Communications and serve on Communication and Medical Review Committees.

The ideal candidate will have deep expertise in healthcare law, with a proven track record of advising on legal issues related to patient support, advertising and promotion, scientific exchange, 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.

Key Responsibilities

Strategic Legal Counsel

• Serve as a trusted legal advisor to senior leadership, the U.S. Business Unit Leadership Team and the Pain Disease Strategy and Global Commercialization Pain Teams, providing strategic guidance on commercialization initiatives.
• Provide actionable legal advice on advertising, promotion, scientific exchange, product liability, healthcare fraud and abuse, and other regulatory matters.
• Actively participate in cross-functional teams, including the Disease Area Strategy, Commercialization Strategy, Communication Review, Medical Review, and Label Review Committees, ensuring compliance and alignment with business goals.
• Stay ahead of evolving healthcare laws, regulations, and enforcement trends to proactively address risks and opportunities.

Leadership and Collaboration

• Lead and mentor cross-functional teams, fostering a culture of collaboration, innovation, and compliance.
• Build strong relationships with internal stakeholders to align legal strategies with business priorities.
• Contribute to Legal and Compliance Department initiatives, including culture-building and pro bono programs.

Risk Management and Compliance

• Provide expert guidance on healthcare laws, regulations and guidance, including the Food, Drug, and Cosmetic Act and associated regulations, state and federal anti-kickback statutes, the False Claims Act and Lanham Act.
• Serve as a key member of communication review committees, ensuring compliance while supporting business objectives.
• Proactively identify and mitigate legal risks to safeguard the company's integrity and reputation.

Qualifications and Experience

• Juris Doctor (JD) degree from an ABA-accredited law school and active membership in good standing with a state bar.
• Minimum of 10+ years of post-JD experience in healthcare law within the biopharma industry (in-house and/or law firm) supporting pre- and post-launch biopharmaceutical products. Experience in managing strategic alliances is a plus.
• Expertise in healthcare regulatory and compliance matters, including advertising and promotion, fraud and abuse, patient support, scientific exchange, and interactions with healthcare stakeholders.
• Proven ability to navigate and interpret healthcare laws and regulations, including the Food, Drug, and Cosmetic Act, anti-kickback statutes, the False Claims Act, Lanham Act and related regulations and guidance.
• Experience advising communication review committees and providing guidance on FDA's CFL and SIUU guidance.
• Exceptional communication skills, with the ability to convey complex legal concepts to diverse audiences.
• Strategic thinker with excellent analytical and problem-solving skills, focused on practical solutions.

Personal Attributes

The ideal candidate will:

• Demonstrate exceptional interpersonal and communication skills, with the ability to build trust and influence across all levels of the organization.
• Exhibit strong business acumen, ethical decision-making, and a proactive, solutions-oriented mindset.
• Thrive in a fast-paced, dynamic environment while effectively managing multiple priorities.
• Foster collaboration and value diversity and inclusion as key drivers of success.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com