Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Role Summary:
The Franchise Counsel serves as the lead counsel for clinical therapies and pharmaceutical brands. The Franchise Counsel provides 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. They partner closely with Medical, Commercial, Regulatory Affairs, and G&A colleagues.
This role is based in Waltham, MA.
Primary Responsibilities:
Commercialization & Launch Readiness
- 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 & Risk Management
- 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.
#LI-Onsite
The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Top Skills
Dyne Therapeutics Waltham, Massachusetts, USA Office
1560 Trapelo Rd, Waltham, MA, United States, 02451
Similar Jobs
What you need to know about the Boston Tech Scene
Key Facts About Boston Tech
- Number of Tech Workers: 269,000; 9.4% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Thermo Fisher Scientific, Toast, Klaviyo, HubSpot, DraftKings
- Key Industries: Artificial intelligence, biotechnology, robotics, software, aerospace
- Funding Landscape: $15.7 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Summit Partners, Volition Capital, Bain Capital Ventures, MassVentures, Highland Capital Partners
- Research Centers and Universities: MIT, Harvard University, Boston College, Tufts University, Boston University, Northeastern University, Smithsonian Astrophysical Observatory, National Bureau of Economic Research, Broad Institute, Lowell Center for Space Science & Technology, National Emerging Infectious Diseases Laboratories
