Senior Director/Director, Compliance

Mirum focuses on finding and developing drugs for difficult-to-treat liver diseases. Our programs are focused on cholestatic liver disease in children and adults.  Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.

POSITION SUMMARY

The Sr. Director/Director, Compliance 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

  • Manage continual development and implementation of Mirum’s compliance policies
  • Interpret applicable laws, regulations, and related compliance landscape toward providing practical, timely solutions to meet dynamic business needs
  • 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
  • Oversee Mirum’s Learning Management System and assist in the development of organizational training curriculum
  • Provide ongoing healthcare compliance training for new hires and as needed
  • Facilitate risk management forums, such as grant review and material review
  • Manage logistics for Federal and State Sunshine reporting and related healthcare compliance posting requirements
  • Assist with investigations regarding matters of observed, reported or suspected non-compliance and collaborate with functional heads as needed toward implementing necessary corrective actions
  • Conduct compliance monitoring, including field ride-alongs and medical congress audits
  • Support Privacy initiatives for HIPAA and GDPR compliance
  • Represent Mirum in industry compliance forums

QUALIFICATIONS

Education/Experience:

  • Advanced degree required
  • Minimum 7 years as a compliance officer in a biotech/pharma organization
  • 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
  • Good conflict management and negotiation skills
  • Ability to 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

To apply, please send your resume to careers@mirumpharma.com.