Director, Safety Operations

Mirum focuses on finding and developing drugs for difficult to treat liver diseases.  Our lead program is focused on two severe liver diseases in children, Alagille Syndrome and progressive familial intrahepatic cholestasis (PFIC).  Both conditions can result in severe itching, liver damage and a need for liver transplant.  Based on a wealth of data from clinical trials spanning multiple years and involving more than one hundred patients, we believe our approach can address the underlying cause of symptoms and liver damage.  Our goal is to give families their lives back.

POSITION SUMMARY:

This position reports to the CMO and encompasses management of the day-to-day functions of Medical Safety (MS) Operations. This role collaborates with colleagues and vendors including Clinical Development, Clinical Operations, Biometrics, Regulatory Affairs (RA), Quality Assurance (QA), Medical Affairs and Legal.

 PRIMARY RESPONSIBILITIES:

  • Accountable for developing the overall MS road map to maintain quality, training, compliance, and inspection readiness.
  • Establishes strategy for the MS systems plan and outsourcing model (e.g. ICSR process, safety database, CROs, call centers, etc.).
  • Accountable for processing and reporting of ICSRs from all sources and ensuring compliance and quality according to company procedures and regulatory requirements.
  • Ensures that expedited and periodic safety reports to regulatory agencies and license partners are submitted and compliance is tracked.
  • Liaises with assigned Clinical Reviewer to ensure that appropriate review and assessment is provided for ICSRs.
  • Safety data extraction and production from MS systems for internal partners and regulatory submissions.
  • Oversee receipt and submission reconciliation between license partners and vendors and serious adverse event (SAE) reconciliation between the clinical and safety databases.
  • Collaboration with QA on product complaints associated with ICSRs.
  • Direct management of interactions with MS Operations vendor including maintenance of Safety Management Plans and set-up of safety systems.
  • Ensures clinical study management team representation and support.
  • Manages the development of an inspection ready function to support MS and the wider company organization including:
    • MS contributions to the Quality Management System and Compliance Dashboard
    • Document control and retention

QUALIFICATIONS:

  • Master’s degree in life sciences, MD, PhD, PharmD, BSN/RN preferred.
  • Minimum 8 years of drug safety, clinical research, or healthcare related experience preferred; oncology experience highly desired.
  • Minimum of 4 years direct pharmaceutical industry experience dealing with global clinical study safety processing and reporting preferred; global post-approval safety experience highly desired.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Safety database experience required; Argus preferred
  • Proficient in MS Word, Excel, PowerPoint, Outlook and other applicable business software tools.
  • Detailed knowledge of relevant US, EU and ICH guidelines, initiatives and regulations governing both clinical studies and post-approval safety.
  • Ability to travel both domestically and internationally (<10%)
  • Proficient in MS Word, Excel, PowerPoint, Outlook and other applicable business software tools.

Please submit your resume to careers@mirumpharma.com

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