Director, Compliance
The Director of Compliance at Dyne Therapeutics is responsible for providing guidance on a wide range of commercialization issues as the company scales and prepares for the launch of its first therapies. Key responsibilities include:
Design and implement a comprehensive health care compliance program consistent with all laws, regulations, policies, and industry standards.
Establish and refresh corporate policies, procedures, and guidelines to ensure compliant operations across all Commercial, Medical, and research activities.
Lead risk assessments to identify and prioritize compliance risks.
Develop and deliver risk-based compliance training for employees.
Develop and implement auditing & monitoring plans and related dashboards.
Lead confidential, thorough investigations into potential violations.
Establish Compliance as a solutions-oriented business partner, collaborating closely with the Franchise Counsel to align on consistent, actionable legal and compliance solutions.
Champion Dyne's core values and culture of integrity, serving as a trusted advisor to senior leadership and cross-functional teams on business and compliance strategies.
Requirements include:
An advanced degree in law, business administration, or a related field.
At least 10+ years of overall professional experience, including at least 7+ years of healthcare compliance experience, ideally within a global rare disease biotechnology company.
Deep expertise in U.S. health care laws, federal health care programs, and therapy launches.
A strong understanding of PhRMA Code, Anti-Kickback Statute, False Claims Act, data privacy, and transparency laws.
Experience supporting compliant patient engagement, HCP engagement, scientific exchange, and innovative patient support programs.
Proven success advising cross-functional teams (Medical, Commercial, Regulatory, Technical Operations, and G&A) on complex, time-sensitive matters.
Exceptional communication, analytical, and project management skills with attention to detail and execution excellence.
A collaborative leadership style and enterprise mindset that reinforces organizational culture and values.
This role is based in Waltham, MA, without the possibility of being a remote role. Dyne offers a competitive salary range of $200,000—$270,000 USD, reflecting 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.