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.
POSTION SUMMARY
The Director, Compliance Operations is responsible for the support and continual development of Mirum’s comprehensive compliance program to help ensure that the Company meets its ethical and legal obligations to patients, healthcare professionals, employees, investors and other stakeholders.
JOB FUNCTIONS/RESPONSIBILITIES
- Lead and manage all aspects of federal and state transparency (Sunshine Act/Open Payments and similar state requirements) and aggregate spend reporting requirements.
- Monitor and analyze data for trends, anomalies and compliance gaps.
- Manage ongoing development and execution of Mirum’s risk-based auditing and monitoring program to ensure compliance with applicable laws, regulations and company policies.
- Work with third-party vendors and internal stakeholders to ensure compliance with state licensing, registration and renewal requirements.
- Manage continual development and implementation of Mirum’s compliance policies.
- Champion Company culture in which employees view compliance as aligned with core values and regard it as a key objective in business decisions and process development.
- Partner with legal, regulatory, finance, quality and other departments to support compliance-related initiatives and resolve operational compliance issues.
- Assist with ongoing management of training curriculum and healthcare compliance training as needed.
- Assist with investigations regarding matters of observed, reported or suspected non-compliance and collaborate with functional heads as needed toward implementing necessary corrective actions.
- Support Privacy initiatives for HIPAA and GDPR compliance as needed.
- Represent Mirum in industry compliance forums.
- Participate in ride-long monitoring activities as needed.
QUALIFICATIONS
Education/Experience:
- Bachelor’s degree required; advanced degree preferred.
- Minimum 7-10 years of US healthcare compliance experience in a biotech/pharma organization.
- Demonstrated operational compliance expertise, including hands-on experience with transparency reporting, auditing/monitoring and training.
- Familiarity with state and federal licensing and registration requirements.
- Experienced in the development, initiation, maintenance, and enforcement of policies and procedures for the operation of a Compliance Program.
- Demonstrated collaborations working with senior business leaders, attorneys, law enforcement professionals, and regulators.
- Experience in supporting investigations and managing the investigative process.
- Rare disease commercial launch experience preferred but not required.
- Systems implementation/oversight experience preferred.
Knowledge, Skills and Abilities:
- Excellent interpersonal skills, ability to develop important relationships with key stakeholders; a solutions-oriented collaborator.
- Strong knowledge of relevant regulations and related obligations.
- Good conflict management and negotiation skills.
- Excellent organizational, communication and leadership skills.
- Ability to work independently, and analyze complex issues to develop relevant and realistic plans, programs and recommendations.
- Strong written, verbal, and presentation skills.
- Willingness to embrace and champion Company core values.
- Ability to travel on occasion when necessary.
The salary range for this position is $200,000 to $225,000 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.
Top Skills
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.
