Director, Compliance Business Partner

About the role

Reporting into the Executive Director, Head of US Compliance, the Director, US Compliance – Business Partner is a key leadership position, and it's so much more than a traditional compliance role. At its heart, this position is all about partnership. You'll work hand-in-hand with a wide range of Insmed's US business functions, serving as a trusted advisor and go-to resource for compliance guidance.

Whether it's collaborating with the Neuro & Other Rare Therapeutic Area Program Teams, supporting exciting business opportunities, or contributing to a variety of other innovative business programs, you'll be right at the center of the action, helping teams navigate the compliance landscape with confidence and clarity. This role also offers the opportunity to make a broader impact across the organization.

Responsibilities

• Serve as a dedicated Compliance partner providing proactive, risk-based guidance on applicable laws, regulations, and industry standards, as the programs advance through clinical development and commercialization.
• Engage early and consistently to identify and address compliance considerations unique to gene therapies and rare diseases, including patient access, expand access programs, and interactions with healthcare professionals.
• Extend ongoing Compliance guidance and support to other Program Teams across the organization, as assigned, serving as a trusted advisor and subject matter expert throughout the product lifecycle, from clinical trials, launch, and post-market activities.
• Foster a culture of compliance by proactively engaging with program stakeholders, delivering targeted training, reviewing materials, and offering practical, business-oriented solutions to complex compliance challenges.
• Attend cross-functional team meetings, actively fostering stakeholder engagement.
• Oversee the implementation of mitigation plans and processes to facilitate appropriate follow-up and close-out of compliance issues as identified by monitoring and auditing team. Provide support to the Internal Investigation Committee for Compliance related items, as needed.
• Review materials (presentations, training materials, HCP materials, data dashboards, etc.) and other activities for functional areas as assigned.
• Develop and facilitate Compliance training (e-learning and live) for functional areas assigned.
• Develop, review and update Policies and SOPs both Compliance departmental and representing Compliance on functional review of SOPs.
• Support a proactive approach to compliance that is focused on partnerships, prevention, and risk mitigation, develop plans and deliverables to inform relevant internal functions.
• Raise awareness of the Compliance program and foster accountability for compliance within the business.
• Promote a continuous improvement mindset and propose enhancements to the Compliance Program informed by industry trends and best practices.

Requirements

• A minimum of a Bachelor’s Degree in a related field as well as 10+ years’ experience in US Healthcare, with significant experience in US HCC for a pharmaceutical or biotech company, including but not limited to Project Management, Learning and Training, Quality Management System, Auditing and Monitoring, Data Analytics, Policy/SOP Development, Risk Assessment and Investigations.
• In-depth knowledge and understanding of applicable HCC laws and guidance, including but not limited to OIG guidelines, AMA guidelines, PhRMA Code, Corporate Integrity Agreements, Anti-Kickback, False Claims Act, and US transparency laws and reporting processes.
• Direct, hands-on experience working within a Gene Therapy organization that possesses a high-level familiarity with the unique compliance risks associated with this space in the U.S. business context, highly preferred.
• Proven experience building, implementing, and managing an effective compliance program in a growing commercial biotech environment, ideally with experience related to product launches.
• Experience in continuous improvement for compliance programs.
• Demonstrated ability to work collaboratively and effectively with diverse cross-functional teams and senior leadership.
• High ethical standards and a proven track record of integrity and sound judgement.

Qualifications

• Minimum of a Bachelor’s Degree in a related field.
• 10+ years’ experience in US Healthcare, with significant experience in US HCC for a pharmaceutical or biotech company.
• Significant experience in US HCC for a pharmaceutical or biotech company, including but not limited to Project Management, Learning and Training, Quality Management System, Auditing and Monitoring, Data Analytics, Policy/SOP Development, Risk Assessment and Investigations.
• In-depth knowledge and understanding of applicable HCC laws and guidance, including but not limited to OIG guidelines, AMA guidelines, PhRMA Code, Corporate Integrity Agreements, Anti-Kickback, False Claims Act, and US transparency laws and reporting processes.
• Direct, hands-on experience working within a Gene Therapy organization that possesses a high-level familiarity with the unique compliance risks associated with this space in the U.S. business context, highly preferred.
• Proven experience building, implementing, and managing an effective compliance program in a growing commercial biotech environment, ideally with experience related to product launches.
• Experience in continuous improvement for compliance programs.
• Demonstrated ability to work collaboratively and effectively with diverse cross-functional teams and senior leadership.
• High ethical standards and a proven track record of integrity and sound judgement.