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.
The Clinical Scientist (CS) role is a newly created position requiring a strong leader who will provide technical and operational leadership, and to support the development of our medicinal products. We are seeking a highly motivated, Clinical Scientist who has experience with global clinical trials, hepatology and in-depth knowledge of global clinical trial regulations. The CS is responsible for program and study level scientific, medical and operational 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.
- Responsible for drafting key clinical trial documents in collaboration with Clinical Operations, Biostats, Medical Writing and the CROs.
- Supports the medical monitoring of efficacy, safety and laboratory data received from the clinical trials.
- Works directly with the investigational sites to ensure a seamless exchange of support and information during the study work up, ongoing trials and closure.
- Responsible for the clinical aspects of the Data Review Plan.
- Support the analysis and drafting of clinical trial and scientific publications.
- Works closely with Clinical Operations and Data Management for CRF design.
- Supports investigational site start ups and will present on behalf of Clinical Development.
- Ensure the TMF is completed for Clinical development requirements.
Support the running and operational aspects of the Clinical Development team including meeting support, inspection readiness and organizational support.
- Bachelor’s Degree in a scientific discipline.
- 6+ years of experience in the pharmaceutical industry, including 3+ years in Clinical Development teams.
- Manage several clinical trials with multidisciplinary trial teams.
- Experience in fully outsourced CRO models.
- Medical/scientific expertise appropriate to clinical program.
- Demonstrates ability to establish strong scientific partnership 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.
Knowledge, Skills and Abilities:
- Demonstrates excellent scientific writing skills.
- Demonstrates knowledge and application of statistical analysis methodology and can identify trends and interpret and report data effectively.
- In-depth knowledge of drug development processes.
- Strong verbal and written communication.
To apply, please send your resume to firstname.lastname@example.org.