Senior Director, Franchise Counsel

Role Summary

In this role, the Franchise Counsel will serve as the lead counsel for clinical therapies and pharmaceutical brands. The Franchise Counsel will provide legal guidance on a wide range of commercialization issues as Dyne scales and prepares for the anticipated launch of its first therapies. These topics include advertising and promotion, compliance with FDA regulations, health care fraud and abuse laws, Value & Access matters, patient support programs, data privacy, and various federal and state laws governing the pharmaceutical industry. The Franchise Counsel will work closely with Medical, Commercial, Regulatory Affairs and G&A colleagues.

This role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.

Responsibilities

• Serve as lead counsel for Dyne's therapeutic franchises, advising on commercial and medical strategies from development through launch.
• Provide legal review and counsel for promotional and non-promotional materials, including sales and marketing collateral, scientific exchange, digital media, and disease-state education.
• Advise on pricing, value & access strategies, contracting, trade and distribution matters, and patient access programs to ensure compliance with FDA, OIG, and industry standards.
• Support launch, inspection, and filing readiness activities across cross-functional teams.

Compliance

• Advise on FDA regulations, federal and state fraud and abuse laws, and obligations under U.S. federal health care programs.
• Support the development, implementation, and monitoring of Dyne's compliance program.
• Review and approve grants, sponsorships, and medical education programs in alignment with company policy and industry codes.
• Oversee transparency reporting, data privacy (including GDPR and U.S. state laws), and other global health care compliance obligations.
• Partner with Legal and Compliance colleagues to provide training and proactive risk assessments.

Business Partnership & Leadership

• Act as the primary legal business partner to key functions including Commercial, Medical Affairs, Regulatory, and G&A.
• Represent Legal on cross-functional project and governance teams to support launch readiness and commercial objectives.
• Collaborate with internal stakeholders and external partners to ensure compliant and effective business operations.
• Help mature Dyne's health care law capabilities and identify opportunities for process improvement and proactive legal risk management.
• Support the Head of Legal in health care, compliance, and operational matters.

Education, Knowledge & Skill Requirements

• JD from an accredited law school; licensed to practice in at least one U.S. jurisdiction.
• 10+ years of health care law and compliance experience, ideally within a global biotechnology company and a top-tier law firm.
• Deep expertise in FDA regulations, U.S. health care laws, and federal health care programs; familiarity with ex-U.S. frameworks (e.g., EFPIA, GDPR).
• Strong understanding of PhRMA Code, Anti-Kickback Statute, False Claims Act, data privacy, and transparency laws.
• Demonstrated content review committee experience in the pharmaceutical industry.
• Proven success advising cross-functional teams (Medical, Commercial, Regulatory, Technical Operations, and G&A) on complex, time-sensitive matters.
• Skilled at balancing strategic legal guidance with practical business judgment in fast-paced, evolving environments.
• Exceptional communication, analytical, and project management skills with attention to detail and execution excellence.
• Collaborative leadership style and enterprise mindset that reinforces organizational culture and values.
• Experience thriving in a small, rapidly growing biotech or start-up environment with a solutions-oriented approach.