At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.
For patients, for each other, and for the future of science, we’re in. Are you?
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.What You'll Do:
In this role, you’ll have the opportunity to collaborate actively and build strong, trust-based partnerships with key internal functions and cross-functional stakeholders across the organization to ensure that Compliance is embedded as a strategic enabler throughout all stages of program development and business growth. This includes, but is not limited to:
Neuro & Other Rare Program Teams: 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.
Other Program Teams: 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.
You’ll also:
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. This may include assisting with information gathering, offering guidance on processes or compliance considerations, and collaborating with team members to help drive investigations forward in an efficient and thoughtful way.
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.
Who You Are:
You have 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.
You are or you have:
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.
Nice to have (but not required)
HCC Certifications.
Travel Requirements
This role requires occasional travel (approximately 5%–15%).
#remote
#LI-EG1
Pay Range:
$185,000.00-252,500.00 AnnualLife at Insmed
At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.
Highlights of our U.S. offerings include:
Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back
Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.
Current Insmed Employees: Please apply via the Jobs Hub in Workday.
Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
For New York City Residents:
To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool (“AEDT”) that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review.
If you are an applicant for this role and a New York City resident, you have the right to request:
A reasonable accommodation, if one is available under applicable law, by emailing TotalRewards@insmed.com
An alternative selection process by emailing Privacy@insmed.com.
Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at Privacy@insmed.com.