Senior Manager, Compliance Operations & Analytics
Job Summary
The Senior Manager, Compliance Operations & Analytics supports the strategic development, implementation, and enhancement of Mirum’s global healthcare compliance program. This role partners cross-functionally across various departments to ensure the Company meets its ethical and legal obligations.
Job Functions/Responsibilities
Support the ongoing development, implementation, and continuous improvement of Mirum’s comprehensive healthcare compliance program.
Assist in the design, enhancement, and operationalization of compliance policies, SOPs, standards, and controls aligned with applicable federal and state healthcare laws, regulations, and industry guidance.
Partner with Commercial, Medical Affairs, Market Access, Patient Services, and other business functions to provide practical, risk-based compliance guidance.
Champion a culture of integrity and accountability in which employees view compliance as aligned with Mirum’s core values and business objectives.
Support compliance committee activities, risk assessments, and remediation tracking.
Oversee third-party compliance due diligence and monitoring activities.
Transparency Reporting Ownership
Lead operational execution and ongoing enhancement of Federal Open Payments (Sunshine Act) and applicable state transparency reporting processes.
Partner with Finance, Commercial Operations, Medical Affairs, and vendors to ensure accurate and timely data collection and reporting.
Oversee pre-submission review, dispute resolution support, and post-submission reconciliation activities.
Monitor evolving transparency reporting regulations and assess and update business process impacts as needed.
Drive process improvements and automation initiatives to strengthen reporting accuracy, efficiency, and audit readiness.
Compliance Analytics & Monitoring
Design, develop, and execute risk-based compliance monitoring and analytics programs using internal and external data sources.
Conduct compliance audit activities to identify opportunities for field ride-alongs, speaker program reviews, medical congress audits, expense monitoring, and targeted transactional reviews.
Develop dashboards, KPIs, trend analyses, and reporting metrics to identify potential compliance risks and inform leadership decision-making.
Partner with business stakeholders to develop corrective action plans and monitor remediation activities.
Assess audit and monitoring outcomes and develop and maintain resources to further mitigate risk and address concerns.
AI, Technology & Process Innovation
Evaluate and implement technology-enabled compliance solutions, including AI-assisted monitoring, analytics, workflow automation, and reporting tools.
Utilize AI and data analytics to proactively identify trends that may assist in developing future audit/monitoring plans.
Partner with IT, Legal, Privacy, and business stakeholders to assess appropriate governance and controls for the use of AI within compliance-related processes.
Support development of governance frameworks and policies related to responsible AI use, data privacy, and compliance oversight.
Stay informed on emerging industry trends and best practices related to AI-enabled compliance operations.
Qualifications
Education / Experience: Bachelor’s degree required; advanced degree (JD, MBA, MPH, MS, or equivalent) preferred. 5+ years of healthcare compliance, compliance operations, audit, analytics, or related experience within the biotechnology, pharmaceutical, or life sciences industry. Experience within a small to mid-size biotechnology organization strongly preferred.
Demonstrated experience supporting or leading operational aspects of a healthcare compliance program.
Strong knowledge of applicable healthcare compliance laws and regulations, including the Anti-Kickback Statute, PhRMA Code, FDA promotional requirements, Open Payments/Sunshine Act, state transparency laws, and related compliance obligations.
Direct experience managing or overseeing Sunshine Act/Open Payments and state transparency reporting operations required.
Experience developing and executing compliance monitoring, auditing, and analytics programs/dashboards.
Experience leveraging data analytics, reporting tools, and visualization platforms (e.g., Power BI, Tableau, Excel, SQL, or similar tools).
Experience implementing or utilizing AI-enabled compliance tools, automation platforms, or advanced analytics solutions preferred.
Experience collaborating cross-functionally with Commercial, Medical Affairs, Finance, Legal, IT, and other stakeholders.
Rare disease and/or specialty pharmaceutical experience preferred.
Knowledge, Skills & Abilities
Strong analytical mindset with the ability to interpret complex data sets and translate findings into actionable business recommendations.
Strong understanding of compliance analytics methodologies, data governance principles, and risk-based monitoring approaches.
Ability to evaluate emerging technologies, including AI-enabled solutions, and apply them appropriately within a regulated environment.
Excellent interpersonal skills with the ability to build trusted relationships across all levels of the organization.
Solutions-focused approach to complex databases and associated compliance risk management.
Strong project management and organizational skills with the ability to manage multiple priorities simultaneously.
Excellent written, verbal, presentation, and communication skills.
Strong conflict management, collaboration, and negotiation skills.
Ability to work independently while exercising sound judgment and attention to detail.
High level of professionalism, integrity, discretion, and accountability.
Benefits
The salary range for this position is $175,000 to $190,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.
About Mirum Pharmaceuticals
Mirim Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.