Senior Manager, Compliance Operations & Analytics

Posted 4 Days Ago
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Foster City, CA, USA
In-Office
175K-190K Annually
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
Lead and operationalize Mirum's global healthcare compliance program with focus on Open Payments/Sunshine Act and state transparency reporting. Build compliance analytics, monitoring, audits, dashboards, and KPIs. Drive data governance, reconciliation, remediation, and process automation using AI-enabled tools. Partner cross-functionally with Commercial, Medical Affairs, Finance, Legal, IT and vendors to ensure regulatory compliance and continuous improvement.
Summary Generated by Built In

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.

#LI-HYBRID

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.


Skills Required

  • Bachelor's degree
  • 5+ years healthcare compliance, compliance operations, audit, analytics, or related experience in biotech/pharmaceutical/life sciences
  • Direct experience managing Sunshine Act/Open Payments and state transparency reporting operations
  • Strong knowledge of healthcare compliance laws and regulations (Anti-Kickback Statute, PhRMA Code, FDA promotional requirements, Open Payments, state transparency laws)
  • Experience developing and executing compliance monitoring, auditing, and analytics programs and dashboards
  • Experience leveraging data analytics, reporting tools, and visualization platforms (e.g., Power BI, Tableau, Excel, SQL)
  • Experience collaborating cross-functionally with Commercial, Medical Affairs, Finance, Legal, IT, and vendors
  • Advanced degree (JD, MBA, MPH, MS) or equivalent
  • Experience within a small to mid-size biotechnology organization
  • Experience implementing or utilizing AI-enabled compliance tools, automation platforms, or advanced analytics solutions
  • Rare disease and/or specialty pharmaceutical experience

Mirum Pharmaceuticals Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Mirum Pharmaceuticals and has not been reviewed or approved by Mirum Pharmaceuticals.

  • Equity Value & Accessibility Equity grants to new hires and an employee stock purchase plan make ownership more accessible and can boost total rewards when performance is strong. Public disclosures highlight frequent option/RSU inducements.
  • Healthcare Strength Comprehensive medical, dental, and vision coverage is employer-paid for employees, with added life, disability, and EAP support. This combination reduces financial burden and enhances overall wellbeing.
  • Leave & Time Off Breadth A broad time-off program includes multiple paid company holidays, a year-end shutdown, accrued vacation, and paid parental leave. This breadth provides additional rest periods beyond standard vacation.

Mirum Pharmaceuticals Insights

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The Company
HQ: Foster City, CA
200 Employees
Year Founded: 2018

What We Do

Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. Mirum’s approved medication is LIVMARLI® (maralixibat) oral solution which is approved in the U.S. for the treatment of cholestatic pruritus in patients with Alagille syndrome one year of age and older. Mirum’s late-stage pipeline includes two investigational treatments for debilitating liver diseases affecting children and adults. Maralixibat (LIVMARLI), an oral ileal bile acid transporter (IBAT) inhibitor, is currently being evaluated in clinical trials for pediatric liver diseases and includes the MARCH Phase 3 study for progressive familial intrahepatic cholestasis (PFIC) and the EMBARK Phase 2b study for patients with biliary atresia. In addition, Mirum has an expanded access program open in Canada, Australia, the UK and several countries in Europe for eligible patients with Alagille syndrome. Mirum has submitted a Marketing Authorization Application to the European Medicines Agency for maralixibat for the treatment of cholestatic liver disease in patients with Alagille syndrome. Mirum’s second investigational treatment, volixibat, also an oral IBAT inhibitor, is being evaluated in three potentially registrational studies including the OHANA Phase 2b study for pregnant women with intrahepatic cholestasis of pregnancy, VISTAS Phase 2b study for adults with primary sclerosing cholangitis, and the VANTAGE Phase 2b study for primary biliary cholangitis.

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