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.

Primary Responsibilities

• 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.

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.

Pay Range

$200,000 - $270,000 USD