Director, Compliance
Dyne Therapeutics
August 13, 2026
On-site
Waltham, MA
$200,000 - $240,000 USD yearly
Corporate Functions
Role Summary
- Provide compliance guidance on commercialization issues including HCP and patient engagement, disease-state education, FDA compliance, health care fraud and abuse laws, Value & Access, patient support programs, data privacy, and applicable federal/state pharmaceutical laws.
- Design and implement a global compliance program to ensure compliance with all applicable laws, regulations, and ethical codes; partner with Medical, Commercial, Regulatory Affairs, and G&A.
- Based in Waltham, MA (no remote option).
Primary Responsibilities:
- Design and implement a comprehensive health care compliance program.
- Establish and refresh corporate policies, procedures, and guidelines for compliant operations across Commercial, Medical, and research activities.
- Lead risk assessments and prioritize compliance risks.
- Develop and deliver risk-based compliance training.
- Develop and implement auditing & monitoring plans and dashboards.
- Lead confidential investigations into potential violations.
- Act as an approachable, solutions-oriented compliance partner.
- Collaborate with Franchise Counsel on actionable legal/compliance solutions.
- Champion integrity and core values; serve as a trusted advisor to senior leadership and cross-functional teams.
Experience & Skills Requirements:
- Advanced degree in law, business administration, or related field.
- 10+ years professional experience, including 7+ years healthcare compliance (ideally in global rare-disease biotech).
- Deep expertise in U.S. health care laws, federal health care programs, and therapy launches.
- Strong knowledge of PhRMA Code, Anti-Kickback Statute, False Claims Act, data privacy, and transparency laws.
- Experience supporting compliant patient/HCP engagement, scientific exchange, and innovative patient support programs.
- Proven success advising cross-functional teams on complex, time-sensitive matters.
- Strong strategic/practical judgment in fast-paced environments; exceptional communication/analytical/project management.
- Collaborative leadership; able to thrive in small, rapidly growing biotech/start-up.
Pay Range:
- $200,000–$270,000 USD
- Provide compliance guidance on commercialization issues including HCP and patient engagement, disease-state education, FDA compliance, health care fraud and abuse laws, Value & Access, patient support programs, data privacy, and applicable federal/state pharmaceutical laws.
- Design and implement a global compliance program to ensure compliance with all applicable laws, regulations, and ethical codes; partner with Medical, Commercial, Regulatory Affairs, and G&A.
- Based in Waltham, MA (no remote option).
Primary Responsibilities:
- Design and implement a comprehensive health care compliance program.
- Establish and refresh corporate policies, procedures, and guidelines for compliant operations across Commercial, Medical, and research activities.
- Lead risk assessments and prioritize compliance risks.
- Develop and deliver risk-based compliance training.
- Develop and implement auditing & monitoring plans and dashboards.
- Lead confidential investigations into potential violations.
- Act as an approachable, solutions-oriented compliance partner.
- Collaborate with Franchise Counsel on actionable legal/compliance solutions.
- Champion integrity and core values; serve as a trusted advisor to senior leadership and cross-functional teams.
Experience & Skills Requirements:
- Advanced degree in law, business administration, or related field.
- 10+ years professional experience, including 7+ years healthcare compliance (ideally in global rare-disease biotech).
- Deep expertise in U.S. health care laws, federal health care programs, and therapy launches.
- Strong knowledge of PhRMA Code, Anti-Kickback Statute, False Claims Act, data privacy, and transparency laws.
- Experience supporting compliant patient/HCP engagement, scientific exchange, and innovative patient support programs.
- Proven success advising cross-functional teams on complex, time-sensitive matters.
- Strong strategic/practical judgment in fast-paced environments; exceptional communication/analytical/project management.
- Collaborative leadership; able to thrive in small, rapidly growing biotech/start-up.
Pay Range:
- $200,000–$270,000 USD