Director, Compliance
Dyne Therapeutics · Waltham, MA · 1 mo ago
Management$200k–$270k/yrFull-time
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.
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
MA Pay Range
$200,000 - $270,000 USD