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 position is responsible for the overall management and coordination of operational activities involved in the planning, conduct and completion of clinical trials including the management of deliverables, adherence to budget, and ongoing risk mitigation. Manages selected CROs and leads cross functional project teams (clinical monitoring, data management, biostatistics, medical writing, medical affairs, regulatory affairs, and clinical QA) to ensure the project is completed on time, within budget, and with high quality.
- Drive the planning, development and execution of timelines, while identifying and tracking the team’s critical path.
- Facilitate the project team kick-off meeting by identifying key stakeholders and resources.
- Execute and control project activities, including scope, schedule, budget and risk associated with each assigned project and report performance to senior management.
- Establish communication plans for information distribution to team members.
- Manage project/program meetings.
- Conduct project/program reviews at significant milestones or gates to evaluate successes as compared to baseline estimates.
- Integrate understanding of constraints across and within projects and recommend alternatives.
- 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).
- Assist the scientific staff in developing and reviewing protocols, investigator brochures, informed consent forms, clinical study reports and other scientific documents.
- Assist with regulatory submission preparations.
- Author/Oversee the development of plans and execution of those plans related to site monitoring, safety management, data management and biostatistics.
- Identify, evaluate, and select external vendors (central lab, CROs, consultants/contractors).
- Train and manage CROs and other clinical vendor activities to ensure the quality meets Mirum and regulatory requirements.
- Perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance. Develops/reviews and approves study plans.
- Develop contracts for and perform ongoing management of vendors to ensure deliverables and performance adhere to contract.
- Oversee the identification, selection and proper initiation of sites.
- Develop patient recruitment strategies to ensure goals are achieved.
- Oversee development of CRFs, and clinical databases, support development of safety databases, and shell Tables, Figures and Listings.
- Plan, coordinate and conduct investigator meetings.
- Contribute to planning, coordination and conduct of Data Monitoring Committee (DMC) meetings.
- With Medical and Safety, assess trends in data including adverse events, protocol violations, etc.
- Oversee timely database freeze and database lock. Participate in data review meetings.
- Oversee maintenance of the Trial Master File for each project and oversee the archival process.
- Ensure adherence to SOPs, Good Clinical Practice and ICH regulations.
- Bachelor’s degree or equivalent in the life sciences or related field required. Additional coursework or certifications in clinical trial planning and operations desired.
- At least 5 years of relevant experience with project management and clinical development.
- Experience in rare disease and pediatrics is a plus.
- Experience in small, fast-paced biotech is a plus.
- Experience working in a fully outsourced model is a plus.
- Demonstrated experience coordinating interdepartmental activities and efforts to meet protocol and program goals.
- Expert and extensive knowledge of CRO / vendor management and global protocol operations.
Knowledge, Skills and Abilities:
- Must have a demonstrated working knowledge of GCP, ICH guidelines, and regulations.
- Proficiency in resource planning and financial management (clinical trial budgeting) required.
- Ability to deal with multiple priorities with aggressive timelines.
- Strong oral and written communication skills.
- Strong social skills to build relationships with Investigators and site staff.
- Ability to work with minimal supervision, take initiative and complete tasks to deadlines, and resolve/elevate problems in a timely manner.
- Ability to find creative solutions to issues impacting timelines and budgets.
- This is a high-growth, fast-paced small organization. The ability to be productive and successful in a fast-paced work environment is critical.
- Willingness and ability to travel domestically and internationally is required; it is anticipated that this will be 10% of work time.