Director, Compliance

Role Summary:

The Director of Compliance provides compliance guidance on a wide range of commercialization issues as Dyne scales and prepares for the anticipated launch of its first therapies. These topics include HCP and patient engagement, disease‑state education, 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 Director of Compliance helps design and implement a global compliance program to ensure that Dyne complies with all applicable laws, regulations, and ethical codes where the company operates. The Director of Compliance works closely with Medical, Commercial, Regulatory Affairs, and G&A colleagues. We seek a strategic, collaborative, solutions‑oriented leader with deep knowledge and experience. Prior rare‑disease and launch experience enables the Director of Compliance to help Dyne navigate the challenges of our first therapy launches. 

This role is based in Waltham, MA, without the possibility of being a remote role.  

 
Primary 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 an approachable, knowledgeable, practical, helpful, solutions-oriented business partner. 
• Collaborate closely with the Franchise Counsel to align on consistent, actionable legal and compliance solutions. 
• Champion Dyne’s core values and culture of integrity. 
• Serve as a trusted advisor to senior leadership and cross-functional teams on business and compliance strategies. 
• Perform additional duties as required. 

Education, Experience, and Skills Requirements: 

• Advanced degree in law, business administration or related field. 
• 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. 
• 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. 
• Skilled at balancing strategic compliance 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.