MISSION
Mirum 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.
POSITION SUMMARY
The Senior Manager, Compliance Operations & Analytics is responsible for supporting the strategic development, implementation, and ongoing enhancement of Mirum’s global healthcare compliance program. This role partners cross-functionally across Commercial, Medical Affairs, Market Access, Legal, Finance, Privacy, and IT to help ensure the Company meets its ethical and legal obligations to patients, healthcare professionals, employees, investors, and other stakeholders.
This position will lead operational aspects of the compliance program with a strong focus on compliance analytics, open payments and transparency reporting, auditing, and technology-enabled process improvement. The role will be responsible for overseeing federal and state transparency reporting operations, advancing data analytics and monitoring capabilities, and leveraging AI-enabled tools and automation to improve compliance efficiency, insights, and scalability in a growing biotech environment.
The ideal candidate is a proactive and business-oriented compliance professional with demonstrated experience building scalable compliance operations and analytic tools within a small to mid-size biotechnology or pharmaceutical company.
JOB FUNCTIONS/RESPONSIBILITIES
Compliance Operations and Program Management
- 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.
- Assist with management of 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.
- Serve as the primary business owner for transparency reporting operations, including data governance, reconciliation, issue resolution, aggregate spend validation, and cross-functional coordination.
- 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.
- Support internal investigations, audits, and monitoring initiatives as needed.
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) required.
- 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.
- Demonstrated ability to build scalable compliance operations and processes in a fast-paced, growth-oriented environment.
- 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.
- Business-oriented and 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.
- Ability to influence without direct authority and effectively partner across functions.
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.
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Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.
Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.