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 need for liver transplant. We are initiating Phase 3 clinical studies for approval in both settings and have breakthrough status with the FDA in PFIC2.
The Senior Manager, Non-Clinical Programs is responsible for the overall management and coordination of non-clinical activities across programs including the planning, conduct, risk mitigation and completion of non-clinical studies. The Senior Manager will manage the vendors and consultants including deliverables, adherence to budget, and timelines.
- Drive the planning, formation and execution of timelines for assigned non-clinical activities and studies
- Assist the development staff in developing and reviewing protocols, study reports and other scientific documents
- Identify, evaluate, and select external vendors (labs, CROs, consultants/contractors)
- Develop contracts for and perform ongoing management of vendors to ensure deliverables and performance adhere to contract
- Oversee the development of plans and execution of those plans related to non-clinical activities
- Support development of non-clinical sections of regulatory submissions including NDA
- Execute and control project activities, including scope, schedule, budget and risk associated with each assigned project. Report performance to senior management
- Establish communication plans for information distribution to team members
- Identify and track key study metrics in order to identify/anticipate issues (early) and conduct root-cause investigations for issue resolution and/or escalation (as needed)
- Support medical team in management and writing of abstracts and publications
- Potential to work on other projects of scientific interest
- PhD in science required
- Minimum 2 years of industry experience, 5 year experience preferred
- Basic or principal understanding of toxicology studies, pharmacology studies, bioanalytical methods etc., in order to manage and move programs forward with expert consultants
- Experience with writing abstracts and/or manuscripts is preferred
COMPENSATION AND CLASSIFICATION:
- Classification: Full-time position.
- Compensation: Competitive and commensurate with experience; includes equity package.
- Benefits: Medical, dental, and vision, and more.
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