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.
The Clinical Scientist (CS) role is a position requiring a strong candidate who will provide technical and operational leadership and will support the development of our medicinal products. We are seeking a highly motivated scientist who has experience with global clinical trials and in-depth knowledge of global clinical trial regulations; hepatology experience would be a plus. The CS is responsible for program and study level scientific activities during protocol development, trial execution and read-out in compliance with internal processes, GCP/ICH, and regulatory requirements. The Clinical Scientist operates in collaboration with and under supervision of the study and/or program MD; this role is an opportunity for a motivated candidate to shine and make a substantial impact in the clinical development of one or more Mirum assets within a supportive, highly collaborative environment.
- Responsible for drafting or supporting the development of key documents such as clinical trial protocols, IBs, regulatory/ethic committee responses, scientific publications, etc. in collaboration with Clinical Operations, Medical Safety, Biostats, Medical Writing, and CROs.
- Supports the medical monitoring of efficacy, safety and laboratory data received from the clinical trials.
- Works directly with the CRO and/or investigational sites to ensure a seamless exchange of support and information during study startup, ongoing trials and closure.
- Responsible for the clinical aspects of the Data Review Plan.
- Works closely with Clinical Operations and Data Management for CRF design.
- Supports investigational site startups and will present on behalf of Clinical Development.
- Support the running and operational aspects of the Clinical Development team as needed, including meeting support, inspection readiness and organizational support.
- Minimum of Bachelor’s Degree in a scientific discipline; Masters/MD/PhD/PharmD preferred.
- 6+ years of experience in the pharmaceutical industry, including 3+ years in Clinical Development teams.
- Experience in managing clinical trials with multidisciplinary trial teams.
- Scientific expertise appropriate to the clinical program.
- Demonstrated ability to establish strong scientific partnerships with key investigators.
- Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process.
- Advanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss and represent trial or program-level data.
- Experience with clinical data review (e.g., EDC listings, J Review, etc.) is a must.
Knowledge, Skills and Abilities:
- Strong verbal and written communication, with demonstrated excellent scientific writing and presentation skills.
- Demonstrated familiarity with commonly used clinical trial databases, and ability to identify trends and interpret and report data effectively.
- Hands-on mentality, collaborative approach, “get it done” attitude, takes initiative to complete work relatively independently with mentorship/guidance.
To apply, please send your resume to email@example.com.